Clinical Trials

Palbociclib (PD-0332991) is extensively evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4 investigations. Clinical research predominantly targets estrogen receptor-positive and HER2-negative metastatic breast cancer, while also encompassing advanced clear cell renal cell carcinoma, sarcoma, and KRAS-mutant non-small cell lung cancer. Sponsored by industry leaders such as Pfizer alongside institutional sponsors including the National Cancer Institute, Dana-Farber Cancer Institute, and M.D. Anderson Cancer Center, these studies span completed, active, recruiting, and upcoming trials evaluating novel combination regimens.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05725200 RECRUITING
Metastatic Colorectal Cancer
Oslo University Hospital
2022-09-27 PHASE2
NCT03424005 RECRUITING
Metastatic Breast Cancer
Hoffmann-La Roche
2018-03-30 PHASE1; PHASE2
NCT07683754 NOT_YET_RECRUITING
Advanced Breast Cancer; Metastatic Breast Cancer; HER2 Positive; HR Positive
Daiichi Sankyo
2026-09-04 PHASE3
NCT05564377 RECRUITING
Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
2023-04-07 PHASE2
NCT05768139 RECRUITING
Breast Cancer; Solid Tumors, Adult
Eli Lilly and Company
2023-04-17 PHASE1; PHASE2
NCT06380751 RECRUITING
Advanced Breast Cancer
AstraZeneca
2024-08-01 PHASE3
NCT04606446 RECRUITING
Locally Advanced or Metastatic ER+ HER2- Breast Cancer; Locally Advanced or Metastatic Castration-resistant Prostate Cancer; Locally Advanced or Metastatic Non-small Cell Lung Cancer
Pfizer
2020-11-16 PHASE2
NCT07061717 NOT_YET_RECRUITING
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2025-07-01 PHASE3
NCT07748208 NOT_YET_RECRUITING
Breast Cancer; Diabetes Type II
Hoffmann-La Roche
2026-09-01 PHASE2
NCT04802759 RECRUITING
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
Hoffmann-La Roche
2021-06-22 PHASE1; PHASE2
NCT07174336 RECRUITING
Breast Neoplasms; Neoplasm Metastasis
Eli Lilly and Company
2025-12-22 PHASE3
NCT07492641 RECRUITING
HR+/HER2- Breast Cancer
BeOne Medicines
2026-05-22 PHASE3
NCT06757634 RECRUITING
Breast Cancer
Celcuity Inc
2025-07-24 PHASE3
NCT07787520 NOT_YET_RECRUITING
Patients With Advanced Solid Tumors
Laekna Limited
2026-08 PHASE1
NCT06760637 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2025-01-06 PHASE3
NCT06997029 RECRUITING
Advanced Solid Tumor; Advanced Breast Cancer; Advanced Ovarian Cancer
Bristol-Myers Squibb
2025-08-01 PHASE1
NCT02896335 RECRUITING
Metastatic Malignant Neoplasm to Brain; Recurrent Brain Metastases; Progressive Brain Metastases
Massachusetts General Hospital
2017-02-02 PHASE2
NCT06377852 RECRUITING
Metastatic Breast Cancer
American Society of Clinical Oncology
2024-10-29 PHASE3
NCT05554367 ACTIVE_NOT_RECRUITING
Exocrine Pancreas Carcinoma; Malignant Solid Neoplasm; Ovarian Low Grade Serous Adenocarcinoma; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
National Cancer Institute (NCI)
2023-12-13 PHASE2
NCT06843967 RECRUITING
Well Differentiated Liposarcoma; Dedifferentiated Liposarcoma; Liposarcoma; Myxoid Liposarcoma; Round Cell Liposarcoma; Myxoid Pleomorphic Liposarcoma; Pleomorphic Liposarcoma; Unresectable Liposarcoma; Unresectable Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
2025-02-19 PHASE1; PHASE2
NCT06062498 RECRUITING
Estrogen-receptor-positive Breast Cancer; HER2/Neu-Negative Breast Cancer; Advanced Breast Cancerv; Metastatic Breast Cancer
Northwestern University
2023-09-29 PHASE2
NCT06113809 RECRUITING
Sarcoma
John Rieth
2024-02-01 PHASE1
NCT02942355 ACTIVE_NOT_RECRUITING
Female Breast Carcinoma; Breast Cancer
Wake Forest University Health Sciences
2016-12-07 PHASE2
NCT07002177 RECRUITING
Metastatic Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Locally Advanced Breast Cancer (LABC); ER+ Breast Cancer
Forward Pharmaceuticals Co., Ltd.
2025-06-01 PHASE1; PHASE2
NCT04931342 ACTIVE_NOT_RECRUITING
Ovarian Cancer
Hoffmann-La Roche
2021-10-07 PHASE2
NCT04966481 RECRUITING
HPV-unrelated Head and Neck Squamous Cell Carcinoma
Washington University School of Medicine
2022-04-06 PHASE3
NCT03454035 RECRUITING
Tumor, Solid; Pancreatic Cancer; Melanoma
UNC Lineberger Comprehensive Cancer Center
2018-01-30 PHASE1
NCT05867251 RECRUITING
Advanced Solid Tumor; HR+/HER2- Breast Cancer; HR+, HER2-, Advanced Breast Cancer; CCNE1 Amplification; Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer; Endometrial Cancer; TNBC - Triple-Negative Breast Cancer
Avenzo Therapeutics, Inc.
2023-08-30 PHASE1; PHASE2
NCT05627232 RECRUITING
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Thomas Jefferson University
2023-08-28 PHASE1
NCT06692491 NOT_YET_RECRUITING
Rare Tumour
Peking University Shenzhen Hospital
2025-01-01 PHASE2
NCT04567420 ACTIVE_NOT_RECRUITING
Breast Cancer
Criterium, Inc.
2021-02-09 PHASE2
NCT03132454 ACTIVE_NOT_RECRUITING
Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia
M.D. Anderson Cancer Center
2017-07-25 PHASE1
NCT04693468 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm
M.D. Anderson Cancer Center
2020-12-01 PHASE1
NCT05683418 RECRUITING
HR+/HER2-negative Breast Cancer
Totus Medicines
2023-02-15 PHASE1
NCT07191977 NOT_YET_RECRUITING
Esophageal Squamour Cell Cancer
West China Hospital
2026-01 PHASE2
NCT07299890 NOT_YET_RECRUITING
Breast Cancer
Anhui Provincial Cancer Hospital
2025-12-20 PHASE2
NCT04862663 ACTIVE_NOT_RECRUITING
Locally Advanced (Inoperable) or Metastatic Breast Cancer
AstraZeneca
2021-05-10 PHASE3
NCT04563507 RECRUITING
Breast Cancer
Weill Medical College of Cornell University
2020-11-12 PHASE2
NCT07123090 RECRUITING
Metastatic Renal Cell Carcinoma; Metastatic Renal Cancer; Renal Cell Carcinoma; Advanced Clear Cell Renal Cell Carcinoma; Kidney Cancer; Translocation Renal Cell Carcinoma
Stephanie Berg
2025-11-24 PHASE2
NCT06941142 NOT_YET_RECRUITING
Advanced Breast Cancer
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
2025-04-30 PHASE1
NCT04985266 RECRUITING
ER+ Breast Cancer; HER2-negative Breast Cancer
Royal Marsden NHS Foundation Trust
2022-03-30 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
2016-08 PHASE2
NCT06753747 RECRUITING
Esophagus Cancer
West China Hospital
2025-09-10 PHASE1; PHASE2
NCT06188520 RECRUITING
ER+ HER2- Advanced Breast Cancer; High-grade Serous Ovarian Cancer (HGSOC)
AstraZeneca
2023-12-05 PHASE1; PHASE2
NCT04360941 ACTIVE_NOT_RECRUITING
Triple Negative Breast Cancer; Locally Advanced Breast Cancer; Recurrent Breast Cancer; Metastatic Breast Cancer; ER+ Breast Cancer; HER2-positive Breast Cancer
Royal Marsden NHS Foundation Trust
2020-08-11 PHASE1
NCT03304080 ACTIVE_NOT_RECRUITING
Breast Neoplasms; Breast Diseases
Icahn School of Medicine at Mount Sinai
2017-12-20 PHASE1; PHASE2
NCT03332797 ACTIVE_NOT_RECRUITING
Breast Cancer
Genentech, Inc.
2017-11-24 PHASE1
NCT05238922 ACTIVE_NOT_RECRUITING
Solid Tumors
Incyte Corporation
2022-07-05 PHASE1
NCT05432518 RECRUITING
Glioblastoma; Recurrent Disease; Recurrent Glioblastoma
AHS Cancer Control Alberta
2023-06-27 EARLY_PHASE1
NCT04841148 RECRUITING
Breast Cancer
Abramson Cancer Center at Penn Medicine
2021-06-01 PHASE2
NCT05665361 RECRUITING
Advanced Clear Cell Renal Carcinoma (Ccrcc); Papillary Renal Cell Carcinoma (Prcc)
National Cancer Institute (NCI)
2024-04-24 PHASE1; PHASE2
NCT04920708 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer; ER+ Breast Cancer; Advanced Breast Cancer
Royal Marsden NHS Foundation Trust
2022-12-28 PHASE2
NCT05694871 ACTIVE_NOT_RECRUITING
Advanced Dedifferentiated Liposarcoma; Locally Advanced Dedifferentiated Liposarcoma; Metastatic Dedifferentiated Liposarcoma; Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8; Unresectable Dedifferentiated Liposarcoma
Alliance for Clinical Trials in Oncology
2023-06-07 PHASE2
NCT05216432 RECRUITING
PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor
Relay Therapeutics, Inc.
2021-12-08 PHASE1
NCT06736704 RECRUITING
Advanced Solid Tumors
Pikavation Therapeutics, Inc.
2025-02-20 PHASE1; PHASE2
NCT06947811 RECRUITING
EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor
Sun Yat-sen University
2025-06-09 PHASE1; PHASE2
NCT05691400 WITHDRAWN
CYP3A4*22
University of Michigan Rogel Cancer Center
2024-03 PHASE4
NCT06126276 RECRUITING
Malignant Female Reproductive System Neoplasm; Malignant Solid Neoplasm; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm
National Cancer Institute (NCI)
2024-05-07 PHASE2
NCT06065748 RECRUITING
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Hoffmann-La Roche
2023-12-11 PHASE3
NCT06207734 RECRUITING
Breast Cancer
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
2024-01-17 PHASE2
NCT03065062 SUSPENDED
Lung Cancer Squamous Cell; Solid Tumors; Head & Neck Cancer; Pancreatic Cancer
Dana-Farber Cancer Institute
2017-02-28 PHASE1
NCT02465060 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma
National Cancer Institute (NCI)
2015-08-17 PHASE2
NCT03006172 ACTIVE_NOT_RECRUITING
Breast Cancer; Solid Tumor
Genentech, Inc.
2016-12-13 PHASE1
NCT03297606 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
Canadian Cancer Trials Group
2018-03-23 PHASE2
NCT05226871 ACTIVE_NOT_RECRUITING
Breast Cancer; Head and Neck Cancer
Pfizer
2022-07-07 PHASE2
NCT06739395 RECRUITING
Solid Tumor; Precision Medicine
Tianjin Medical University Second Hospital
2024-11-01 PHASE2
NCT04553133 ACTIVE_NOT_RECRUITING
Small Cell Lung Cancer; Ovarian Cancer; Breast Cancer
Pfizer
2020-09-16 PHASE2
NCT05909397 ACTIVE_NOT_RECRUITING
Breast Cancer
Pfizer
2023-08-09 PHASE3
NCT05563220 ACTIVE_NOT_RECRUITING
Breast Cancer; Metastatic Breast Cancer
Stemline Therapeutics, Inc.
2023-01-24 PHASE1; PHASE2
NCT04216576 ACTIVE_NOT_RECRUITING
Breast Cancer
Memorial Sloan Kettering Cancer Center
2019-12-27
NCT04185883 ACTIVE_NOT_RECRUITING
Advanced Solid Tumors; Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Amgen
2019-12-17 PHASE1
NCT02738866 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2016-10-25 PHASE2
NCT04605562 NOT_YET_RECRUITING
Nasopharyngeal Carcinoma
Sun Yat-sen University
2022-06 PHASE2
NCT03820830 ACTIVE_NOT_RECRUITING
Breast Cancer Recurrent
ETOP IBCSG Partners Foundation
2019-08-27 PHASE3
NCT02605486 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer (MBC)
Memorial Sloan Kettering Cancer Center
2015-11-11 PHASE1; PHASE2
NCT05468697 ACTIVE_NOT_RECRUITING
Renal Cell Carcinoma
Merck Sharp & Dohme LLC
2022-08-10 PHASE1; PHASE2
NCT03573648 ACTIVE_NOT_RECRUITING
Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2018-11-13 PHASE2
NCT03609047 ACTIVE_NOT_RECRUITING
Breast Cancer Stage II; Breast Cancer Stage III
European Organisation for Research and Treatment of Cancer - EORTC
2019-06-14 PHASE2
NCT05069038 ACTIVE_NOT_RECRUITING
Breast Cancer
University of Nebraska
2022-03-02 PHASE2
NCT05176288 WITHDRAWN
Advanced Clear Cell Renal Cell Carcinoma
Bradley A. McGregor, MD
2024-05-31 PHASE2
NCT06959979 RECRUITING
Medulloblastoma, Childhood
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2024-11-25 EARLY_PHASE1
NCT04711252 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-01-28 PHASE3
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2020-08-15 PHASE2
NCT05501886 ACTIVE_NOT_RECRUITING
Breast Cancer
Celcuity Inc
2022-12-08 PHASE3
NCT06364956 RECRUITING
Bladder Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2024-05-15 PHASE1; PHASE2
NCT04653740 ACTIVE_NOT_RECRUITING
Advanced Breast Cancer
Centre Oscar Lambret
2020-09-08
NCT04438824 ACTIVE_NOT_RECRUITING
Well-differentiated/Dedifferentiated Liposarcoma
Memorial Sloan Kettering Cancer Center
2020-06-17 PHASE2
NCT05238831 WITHDRAWN
Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8
OHSU Knight Cancer Institute
2023-01-30 EARLY_PHASE1
NCT06570031 COMPLETED
Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer
Ono Pharmaceutical Co., Ltd.
2021-11-09 PHASE1
NCT05969184 COMPLETED
Breast Neoplasm Female
Peking University Cancer Hospital & Institute
2021-12-12 PHASE2
NCT03065387 TERMINATED
Advanced Malignant Solid Neoplasm; EGFR Gene Amplification; EGFR Gene Mutation; ERBB2 Gene Amplification; ERBB2 Gene Mutation; ERBB3 Gene Mutation; ERBB4 Gene Mutation; KRAS Gene Mutation; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm
M.D. Anderson Cancer Center
2017-10-31 PHASE1
NCT05207709 TERMINATED
Metastatic Breast Cancer
SOLTI Breast Cancer Research Group
2022-03-28 PHASE3
NCT05266105 ACTIVE_NOT_RECRUITING
Breast Cancer
Olema Pharmaceuticals, Inc.
2021-12-10 PHASE1
NCT06757335 NOT_YET_RECRUITING
Breast Cancer
Hinova Pharmaceuticals Inc.
2025-01-07 PHASE1; PHASE2
NCT04546009 ACTIVE_NOT_RECRUITING
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
Hoffmann-La Roche
2020-10-09 PHASE3
NCT06478927 RECRUITING
Hepatocellular Carcinoma
Henan Cancer Hospital
2024-01-15
NCT06940349 RECRUITING
Solid Tumors Refractory to Standard Therapy
Rabin Medical Center
2021-10-21 PHASE1; PHASE2
NCT04220476 WITHDRAWN
Breast Cancer
Weill Medical College of Cornell University
2020-03-04 PHASE2
NCT04819243 RECRUITING
Premenopausal HR+/HER2- Metastatic Breast Cancer
Samsung Medical Center
2021-08-25 PHASE2
NCT06810492 NOT_YET_RECRUITING
Breast Cancer Stage III; Breast Cancer Stage II
Hongmei Zheng, PhD
2025-04-01
NCT03478514 ACTIVE_NOT_RECRUITING
Mantle Cell Lymphoma; B Cell Lymphoma
Alliance Foundation Trials, LLC.
2018-09-11 PHASE2
NCT06895733 RECRUITING
Solid Tumor, Adult; Next-generation Sequencing; Precision Medicine
Tianjin Medical University Second Hospital
2024-11-27 PHASE1; PHASE2
NCT06307249 RECRUITING
Cancer; Solid Tumor; Colorectal Cancer; Breast Cancer; Ovarian Cancer; Lung Cancer; Targeted Therapy; Chemotherapy; Immunotherapy; Precision Therapy
Lebanese University
2023-02-15 PHASE1
NCT05190094 RECRUITING
Hormonal Receptors Positive, HER2 Negative, Advanced Breast Cancer
International Cancer Research Group, United Arab Emirates
2022-12-20 PHASE2
NCT04137640 UNKNOWN
Breast Cancer
Shengjing Hospital
2021-07-19 PHASE4
NCT02778685 ACTIVE_NOT_RECRUITING
Metastatic Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
City of Hope Medical Center
2016-09-30 PHASE2
NCT06856200 RECRUITING
Advanced HR - Positive, HER2 - Negative Breast Cancer; Resistant to (Neo)Adjuvant Endocrine Therapy
Fudan University
2025-02-28
NCT04870034 WITHDRAWN
Colorectal Carcinoma; Lung Adenocarcinoma; Malignant Solid Neoplasm; Pancreatic Carcinoma
Roswell Park Cancer Institute
2024-01-15 EARLY_PHASE1
NCT05766410 RECRUITING
Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Therapy
National Taiwan University Hospital
2022-09-16 PHASE2
NCT03423199 UNKNOWN
Breast Neoplasms
National Cancer Center, Japan
2018-02-09 PHASE3
NCT02760030 COMPLETED
Estrogen Receptor and/or Progesterone Receptor Positive; HER2/Neu Negative; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
Ohio State University Comprehensive Cancer Center
2017-02-16 PHASE2
NCT05039177 COMPLETED
Metastatic Colorectal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma
Erasca, Inc.
2021-09-20 PHASE1; PHASE2
NCT03685331 COMPLETED
Metastatic Breast Cancer; Locally Advanced Breast Cancer; Advanced Breast Cancer; BRCA2 Mutation; BRCA1 Mutation
Abramson Cancer Center at Penn Medicine
2020-10-15 PHASE1
NCT05935748 TERMINATED
ccRCC; Clear Cell Renal Cell Carcinoma; Kidney Cancer; Kidney Neoplasms; Renal Cancer; Renal Neoplasms; Recurrent Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Refractory Renal Cell Carcinoma; Advanced Renal Cell Carcinoma; Carcinoma; Neoplasms; Carcinoma, Renal Cell; Neoplasms, Glandular and Epithelial; Neoplasm by Histology; Adenocarcinoma; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases
NiKang Therapeutics, Inc.
2023-07-28 PHASE2
NCT04964934 ACTIVE_NOT_RECRUITING
ER-Positive HER2-Negative Breast Cancer
AstraZeneca
2021-06-30 PHASE3
NCT04498520 WITHDRAWN
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Hormone Receptor Positive Breast Carcinoma; Locally Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Metastatic Endometrioid Adenocarcinoma; Metastatic Fallopian Tube Carcinoma; Metastatic HER2 Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Ovarian Carcinoma; Metastatic Primary Peritoneal Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Refractory Breast Carcinoma; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IVA Fallopian Tube Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVA Primary Peritoneal Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Fallopian Tube Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8; Stage IVB Primary Peritoneal Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8
Pamela Munster
2021-03-31 PHASE1
NCT06654297 ACTIVE_NOT_RECRUITING
Esophageal Squamous Cell Carcinoma
West China Hospital
2024-10-27 PHASE1
NCT03900884 ACTIVE_NOT_RECRUITING
Breast Neoplasm Female
Peter MacCallum Cancer Centre, Australia
2019-09-25 PHASE1
NCT03088059 UNKNOWN
Carcinoma, Squamous Cell of Head and Neck
European Organisation for Research and Treatment of Cancer - EORTC
2017-11-16 PHASE2
NCT05865132 UNKNOWN
Esophagus Squamous Cell Carcinoma
AIPING ZHOU
2023-04-06 PHASE2
NCT03155620 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor
National Cancer Institute (NCI)
2017-07-31 PHASE2
NCT05759949 COMPLETED
PIK3CA Mutation; Solid Tumor, Adult; HER2-negative Breast Cancer; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Unresectable Solid Tumor; Hormone Receptor Positive Tumor
Relay Therapeutics, Inc.
2023-03-29 PHASE1
NCT05277935 UNKNOWN
Breast Neoplasm Female; Quality of Life
Beneficência Portuguesa de São Paulo
2022-04-22
NCT05949424 UNKNOWN
Renal Cell Carcinoma; Ovarian Carcinoma; Thyroid Carcinoma; Breast Carcinoma; Endometrium Carcinoma
University Medical Center Groningen
2024-05 PHASE4
NCT05464173 UNKNOWN
Breast Cancer
Biyun Wang, MD
2022-07-01 PHASE1; PHASE2
NCT05067530 NOT_YET_RECRUITING
Triple Negative Breast Neoplasms
Medical University of Gdansk
2022-01-01 PHASE2
NCT05293964 ACTIVE_NOT_RECRUITING
Breast Cancer
Jiangsu Simcere Pharmaceutical Co., Ltd.
2022-05-18 PHASE1
NCT04720768 UNKNOWN
Melanoma; Metastasis
Peter MacCallum Cancer Centre, Australia
2020-06-04 PHASE1; PHASE2
NCT04591431 UNKNOWN
Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
Fondazione per la Medicina Personalizzata
2020-10-07 PHASE2
NCT06065592 UNKNOWN
Cancer; Solid Tumor; Thromboembolism; Cardiovascular Diseases; Immune System Diseases; Inflammatory Diseases; Colon Cancer; Breast Cancer; Prostate Cancer; Hepatocellular Carcinoma; Lung Cancer; Chemotherapy; Immunotherapy
Lebanese University
2019-02-01 PHASE1
NCT03284957 TERMINATED
Breast Cancer
Sanofi
2017-09-20 PHASE1; PHASE2
NCT02947685 ACTIVE_NOT_RECRUITING
HER-2 Positive Breast Cancer; Estrogen Receptor Positive Breast Cancer
Alliance Foundation Trials, LLC.
2017-06-21 PHASE3
NCT03242382 UNKNOWN
Soft-tissue Sarcoma; Osteosarcoma; Chordoma
Grupo Espanol de Investigacion en Sarcomas
2017-03-31 PHASE2
NCT03616587 ACTIVE_NOT_RECRUITING
ER+ HER2- Advanced Breast Cancer
AstraZeneca
2018-10-11 PHASE1
NCT04072952 COMPLETED
Breast Cancer
Arvinas Estrogen Receptor, Inc.
2019-08-05 PHASE1; PHASE2
NCT03355157 COMPLETED
Metastatic Breast Cancer
GBG Forschungs GmbH
2018-03-01 PHASE4
NCT03709680 ACTIVE_NOT_RECRUITING
Ewing Sarcoma; Solid Tumors; Rhabdoid Tumor; Rhabdomyosarcoma; Neuroblastoma; Medulloblastoma; Diffuse Intrinsic Pontine Glioma
Pfizer
2019-05-24 PHASE2
NCT03870919 ACTIVE_NOT_RECRUITING
Breast Cancer Stage IV; Radiotherapy; Surgery
UNICANCER
2019-10-23
NCT04946864 SUSPENDED
Breast Cancer; Solid Tumor, Adult
Ascentage Pharma Group Inc.
2021-08-13 PHASE1; PHASE2
NCT05655598 WITHDRAWN
Advanced Breast Cancer; Treatment-Refractory Solid Tumors; Retinoblastoma Deficiency; SCLC; Soft Tissue Sarcoma; Endometrial Cancer; Bladder Cancer
Brown University
2023-09-12 PHASE1
NCT05953350 RECRUITING
Inhibition of Autophagy Synergizes Anti-tumor Effect
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
2023-11-07 PHASE1; PHASE2
NCT04858516 UNKNOWN
Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
Guangdong Provincial People's Hospital
2021-04-30 PHASE2
NCT05384119 TERMINATED
Breast Cancer
Tvardi Therapeutics, Incorporated
2023-01-09 PHASE1
NCT03774472 COMPLETED
Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8
M.D. Anderson Cancer Center
2018-08-20 PHASE1; PHASE2
NCT06331715 COMPLETED
Bioequivalence
Megalabs
2024-02-06 PHASE4
NCT05665361 Recruiting
Advanced Clear Cell Renal Carcinoma (Ccrcc)|Papillary Renal Cell Carcinoma (Prcc)
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC)
2024-04-24 Phase 1|Phase 2
NCT03024489 UNKNOWN
Head and Neck Cancer; Locally Advanced
Mahidol University
2017-07-19 PHASE1; PHASE2
NCT06307457 Completed
Breast Cancer
Pfizer
2024-03-11 --
NCT05912933 Not yet recruiting
Breast Cancer
Pfizer
2024-03-01 --
NCT05709158 Not yet recruiting
Breast Cancer
Pfizer
2024-03-01 --
NCT03844997 COMPLETED
Acute Myeloid Leukemia; AML
Sudipto Mukherjee, MD, PhD, MPH
2019-06-06 PHASE1; PHASE2
NCT04334330 UNKNOWN
Breast Cancer; Brain Metastases
Sun Yat-sen University
2020-12-04 PHASE2
NCT04494958 COMPLETED
Triple Negative Breast Cancer
Fundacion Oncosur
2020-11-18 PHASE1; PHASE2
NCT03535506 TERMINATED
DCIS
Georgetown University
2018-10-08 PHASE2
NCT03784014 COMPLETED
Soft Tissue Sarcoma
Institut National de la Santé Et de la Recherche Médicale, France
2019-10-19 PHASE3
NCT02664935 COMPLETED
Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma
University of Birmingham
2015-05-13 PHASE2
NCT03854903 COMPLETED
Metastatic Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone Receptor Positive Breast Cancer
Georgetown University
2019-04-01 PHASE1
NCT05065411 TERMINATED
Metastatic Breast Cancer
Veru Inc.
2022-04-11 PHASE3
NCT03471663 COMPLETED
Breast Cancer
InventisBio Co., Ltd
2018-03-18 PHASE1
NCT04996160 COMPLETED
Acute Lymphoblastic Leukemia, Pediatric; Relapsed Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia
Tanja Andrea Gruber
2021-07-09 PHASE1
NCT05076695 UNKNOWN
Estrogen Receptor-positive Breast Cancer; HER2-positive Breast Cancer
Fudan University
2021-10-15 PHASE2
NCT02448420 COMPLETED
Metastatic Breast Cancer
SOLTI Breast Cancer Research Group
2015-07 PHASE2
NCT04191499 ACTIVE_NOT_RECRUITING
Breast Cancer
Hoffmann-La Roche
2020-01-29 PHASE2; PHASE3
NCT04256941 TERMINATED
Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8
M.D. Anderson Cancer Center
2019-05-31 PHASE2
NCT04818632 COMPLETED
ER+, HER2-, Metastatic Breast Cancer
AstraZeneca
2021-11-12 PHASE1
NCT04060862 TERMINATED
Breast Cancer
Hoffmann-La Roche
2019-11-21 PHASE1
NCT04318223 UNKNOWN
Metastatic Breast Cancer; Locally Advanced Breast Cancer
Consorzio Oncotech
2019-07-16 PHASE2
NCT02668666 COMPLETED
Hormone Receptor Positive Malignant Neoplasm of Breast; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Estrogen Receptor Positive Breast Cancer; Progesterone Receptor Positive Tumor; Metastatic Breast Cancer
Oana Danciu, MD
2017-02-01 PHASE2
NCT03239015 UNKNOWN
Rare Tumor; Refractory Tumor
Baodong Qin
2017-01-01 PHASE2
NCT05178888 COMPLETED
Advanced Solid Tumor
Mirati Therapeutics Inc.
2022-01-20 PHASE1
NCT01356628 COMPLETED
Advanced Hepatocellular Carcinoma; HCC; Liver Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2011-05-25 PHASE2
NCT03446157 COMPLETED
Cancer of the Colon; Colon Cancer; Colon Neoplasms; Colonic Cancer; Neoplasms, Colonic
UNC Lineberger Comprehensive Cancer Center
2018-03-23 PHASE2
NCT04224272 COMPLETED
HER2+/HR+ Breast Cancer
Jazz Pharmaceuticals
2020-06-10 PHASE2
NCT04872608 WITHDRAWN
Metastatic Breast Cancer; Unresectable Breast Cancer
Memorial Sloan Kettering Cancer Center
2021-09-09 PHASE1
NCT04483505 COMPLETED
Breast Cancer Metastatic; Hormone Receptor Positive Malignant Neoplasm of Breast
Fundacion CRIS de Investigación para Vencer el Cáncer
2020-11-25 PHASE1
NCT03526250 COMPLETED
Advanced Malignant Solid Neoplasm; Recurrent Childhood Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Kidney Wilms Tumor; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Glioma; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Refractory Ependymoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Glioma; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma
National Cancer Institute (NCI)
2018-08-13 PHASE2
NCT04736576 COMPLETED
Breast Cancer
Pfizer
2021-02-24
NCT03170206 COMPLETED
Lung Cancer
Dana-Farber Cancer Institute
2017-05-31 PHASE1
NCT03158389 COMPLETED
Glioblastoma, Adult
University Hospital Heidelberg
2018-05-07 PHASE1; PHASE2
NCT02894398 COMPLETED
Breast Cancer; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
iOMEDICO AG
2016-09-06 PHASE2
NCT04247633 UNKNOWN
Breast Cancer
Samsung Medical Center
2020-02-11 PHASE2
NCT04669587 UNKNOWN
Estrogen Receptor-Positive; HER2-Negative; Locally Advanced Breast Cancer; Metastatic Breast Cancer
EnhancedBio USA Inc.
2021-07-26 PHASE1; PHASE2
NCT05244434 WITHDRAWN
Advanced Breast Adenocarcinoma; Advanced HER2-Negative Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIB Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Hormone Receptor-Positive Breast Carcinoma; Metastatic Breast Adenocarcinoma; Metastatic HER2-Negative Breast Carcinoma; Prognostic Stage III Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIB Breast Cancer AJCC v8; Prognostic Stage IIIC Breast Cancer AJCC v8; Prognostic Stage IV Breast Cancer AJCC v8
City of Hope Medical Center
2022-07-03
NCT03054363 COMPLETED
Breast Cancer
University of Colorado, Denver
2017-11-27 PHASE1; PHASE2
NCT03644186 COMPLETED
Breast Cancer; Estrogen Receptor Positive Tumor; HER2-positive Breast Cancer
ETOP IBCSG Partners Foundation
2019-04-16 PHASE2
NCT04858997 UNKNOWN
Breast Neoplasms
Zhejiang Cancer Hospital
2021-04-22 PHASE2
NCT03147287 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
Dana-Farber Cancer Institute
2017-09-05 PHASE2
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
2021-09-23
NCT03386929 TERMINATED
Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB
Worldwide Innovative Network Association
2017-11-29 PHASE1; PHASE2
NCT03959891 ACTIVE_NOT_RECRUITING
Breast Cancer
Massachusetts General Hospital
2019-05-30 PHASE1
NCT03530696 COMPLETED
HER2-positive Breast Cancer; Breast Cancer; Breast Cancer Stage; Recurrent Breast Cancer; Metastatic Breast Cancer; HER2 Positive Breast Carcinoma
University of Arizona
2018-12-06 PHASE2
NCT03110744 COMPLETED
Chordoma
University Hospital Heidelberg
2017-12-15 PHASE2
NCT04129151 TERMINATED
Ewing Sarcoma; Ewing's Sarcoma Recurrent
Dana-Farber Cancer Institute
2019-12-05 PHASE2
NCT03809988 COMPLETED
Breast Cancer; Advanced Breast Cancer; Hormone Receptor Positive Tumor; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
MedSIR
2019-04-05 PHASE2
NCT03691493 COMPLETED
Anatomic Stage IV Breast Cancer AJCC v8; Estrogen Receptor Positive; HER2/Neu Negative; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Bone; Progesterone Receptor Positive; Prognostic Stage IV Breast Cancer AJCC v8
Emory University
2019-02-08 PHASE2
NCT05371275 WITHDRAWN
COVID-19
biotx.ai GmbH
2022-04-21 PHASE2
NCT03455270 COMPLETED
Carcinoma, Ductal, Breast; Breast Cancer Female; Breast Neoplasm; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer; Stage IV Breast Cancer
G1 Therapeutics, Inc.
2018-05-09 PHASE1
NCT02806050 COMPLETED
Breast Cancer
University Medical Center Groningen
2016-09-16 PHASE2
NCT04288089 ACTIVE_NOT_RECRUITING
Receptors, Estrogen; Genes, Erbb-2; Breast Neoplasms
Eisai Inc.
2020-04-01 PHASE1
NCT04478266 TERMINATED
Breast Cancer
Sanofi
2020-10-14 PHASE3
NCT03560856 UNKNOWN
Breast Cancer; HR+/HER2-negative Breast Cancer; Metastasis
Assistance Publique - Hôpitaux de Paris
2018-06-27 PHASE2
NCT02905318 ACTIVE_NOT_RECRUITING
Prostate Cancer
Canadian Cancer Trials Group
2017-07-04 PHASE2
NCT03560531 COMPLETED
Breast Cancer
Zeno Alpha Inc.
2018-11-30 PHASE1; PHASE2
NCT02913430 COMPLETED
Metastatic Breast Cancer
Shannon Puhalla
2018-04-24 EARLY_PHASE1
NCT03128619 TERMINATED
Estrogen Receptor Positive; HER2/Neu Negative; Invasive Breast Carcinoma; Multifocal Breast Carcinoma; Postmenopausal; Progesterone Receptor Positive; Stage I Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
Jonsson Comprehensive Cancer Center
2017-08-02 PHASE1
NCT04856371 UNKNOWN
Advanced Breast Cancer
Haihe Biopharma Co., Ltd.
2021-04 PHASE1
NCT02626507 UNKNOWN
Breast Cancer
Hoffman Oncology
2016-01 PHASE1
NCT03389477 ACTIVE_NOT_RECRUITING
Head and Neck Squamous Cell Carcinoma
Washington University School of Medicine
2018-04-27 PHASE2
NCT02764541 ACTIVE_NOT_RECRUITING
Breast Cancer
Dana-Farber Cancer Institute
2016-05-24 PHASE2
NCT04130152 COMPLETED
Breast Cancer
SOLTI Breast Cancer Research Group
2019-11-21 EARLY_PHASE1
NCT02684032 COMPLETED
Breast Cancer
Celcuity Inc
2016-06-14 PHASE1
NCT03936270 COMPLETED
Ovarian Cancer
Latin American Cooperative Oncology Group
2020-03-05 PHASE2
NCT06390839 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm
National Cancer Institute (NCI)
2017-03-22 PHASE2
NCT03969121 COMPLETED
Breast Cancer Female; Hormone Receptor Positive Malignant Neoplasm of Breast
Kyoto Breast Cancer Research Network
2019-07-16 PHASE3
NCT03220178 TERMINATED
Breast Neoplasm
Palleos Healthcare GmbH
2017-07-24 PHASE4
NCT02917005 UNKNOWN
Metastatic Breast Cancer
Hamdy A. Azim
2019-05-07 PHASE2
NCT02897375 COMPLETED
Solid Neoplasm; Stage III Pancreatic Cancer; Stage IIIA Breast Cancer; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Breast Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Stage IV Non-Small Cell Lung Cancer; Stage IVA Pancreatic Cancer; Stage IVB Pancreatic Cancer; Sarcoma; Colorectal Cancer; Head and Neck Cancer; Cancer of Unknown Primary; Bladder Cancer; Ovarian Cancer
Emory University
2016-10-24 PHASE1
NCT04047758 UNKNOWN
Breast Cancer
Shengjing Hospital
2019-09-01 PHASE3
NCT03965845 COMPLETED
Solid Tumors; NSCLC; CRC; KRAS Gene Mutation
Calithera Biosciences, Inc
2019-06-25 PHASE1; PHASE2
NCT04585724 WITHDRAWN
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8; Metastatic Breast Carcinoma; Metastatic Malignant Neoplasm in the Brain; Prognostic Stage IV Breast Cancer AJCC v8
Emory University
2020-06-12 PHASE1
NCT03284723 TERMINATED
Breast Neoplasms
Pfizer
2017-11-01 PHASE1
NCT03981614 COMPLETED
Metastatic Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8; Unresectable Carcinoma
Academic and Community Cancer Research United
2019-10-29 PHASE2
NCT03472573 COMPLETED
Recurrent B Acute Lymphoblastic Leukemia; Refractory B Acute Lymphoblastic Leukemia
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2018-05-09 PHASE1
NCT02603679 ACTIVE_NOT_RECRUITING
Early-Stage Breast Carcinoma; Estrogen Receptor Positive Tumor
Thomas Hatschek
2015-02 PHASE2
NCT04075604 COMPLETED
Breast Cancer; Cancer
Bristol-Myers Squibb
2019-10-18 PHASE2
NCT04436744 COMPLETED
Early Breast Cancer
Hoffmann-La Roche
2020-09-04 PHASE2
NCT03792256 COMPLETED
Leukemia, Lymphocytic; Lymphoblastic Lymphoma; T-cell Lymphoma; T-cell Leukemia; Recurrent Disease; Acute Leukemia
Children's Oncology Group
2019-04-11 PHASE1
NCT02592746 UNKNOWN
Metastatic Breast Cancer
Samsung Medical Center
2016-06 PHASE2
NCT01976169 COMPLETED
Advanced Breast Cancer
University of Texas Southwestern Medical Center
2014-01-24 PHASE1
NCT03322215 TERMINATED
Breast Cancer Metastatic
Theodoros Foukakis
2017-10-24 PHASE2
NCT03079011 COMPLETED
Metastatic Breast Cancer
UNICANCER
2017-03-22 PHASE3
NCT03238196 COMPLETED
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
2017-08-18 PHASE1
NCT01723774 ACTIVE_NOT_RECRUITING
Breast Neoplasms
Washington University School of Medicine
2013-04-10 PHASE2
NCT03447132 COMPLETED
Breast Neoplasm Female
International Cancer Research Group, United Arab Emirates
2017-12-20 PHASE3
NCT04439201 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm
National Cancer Institute (NCI)
2016-05-31 PHASE2
NCT02384239 COMPLETED
Metastatic Breast Cancer; Hormone Receptor Positive
University of California, San Francisco
2015-10-19 PHASE2
NCT02730429 COMPLETED
Endometrial Cancer
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
2017-02-15 PHASE2
NCT03878524 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma
OHSU Knight Cancer Institute
2020-04-01 PHASE1
NCT02871791 COMPLETED
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone Receptor (HR)-Positive Breast Cancer
Dana-Farber Cancer Institute
2016-08-24 PHASE1; PHASE2
NCT01522989 UNKNOWN
Advanced Solid Tumor Malignancies
Georgetown University
2011-12 PHASE1
NCT03628066 COMPLETED
Breast Cancer
NSABP Foundation Inc
2018-10-22 PHASE2
NCT02513394 ACTIVE_NOT_RECRUITING
Breast Cancer
Alliance Foundation Trials, LLC.
2015-08 PHASE3
NCT03401359 UNKNOWN
Breast Cancer Stage IV
Samsung Medical Center
2017-10-24
NCT03184090 COMPLETED
Metastatic Breast Cancer
MedSIR
2017-06-28 PHASE2
NCT03633331 COMPLETED
Estrogen Receptor-positive Breast Cancer; HER2/Neu Negative; Stage IV Breast Cancer AJCC v6 and v7
Alliance for Clinical Trials in Oncology
2018-08-15 PHASE2
NCT02297438 COMPLETED
Breast Neoplasms
Pfizer
2015-03-23 PHASE3
NCT02536742 COMPLETED
Metastatic Breast Cancer
ETOP IBCSG Partners Foundation
2016-08-30 PHASE2
NCT02907918 TERMINATED
Breast Cancer; Cancer of Breast; Breast Carcinoma
Washington University School of Medicine
2017-06-30 PHASE2
NCT01864746 COMPLETED
Breast Cancer; Hormonreceptor Positive; Her2-normal; Postneoadjuvant Treatment With CDK 4/6 Inhibitor; CPS-EG Score
GBG Forschungs GmbH
2013-10-30 PHASE3
NCT03515200 TERMINATED
Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia With Failed Remission
St. Jude Children's Research Hospital
2018-04-20 PHASE1
NCT02101034 COMPLETED
Carcinoma, Squamous Cell of Head and Neck
Washington University School of Medicine
2014-06-17 PHASE1; PHASE2
NCT02624973 ACTIVE_NOT_RECRUITING
Breast Cancer
Haukeland University Hospital
2016-04-15 PHASE2
NCT02349633 TERMINATED
Non-Small Cell Lung Cancer
Pfizer
2015-05-14 PHASE1; PHASE2
NCT03007979 COMPLETED
Breast Cancer; Breast Carcinoma; Cancer of Breast; Malignant Tumor of Breast
Washington University School of Medicine
2017-06-15 PHASE2
NCT01823835 TERMINATED
Breast Cancer
Genentech, Inc.
2014-12-29 PHASE1; PHASE2
NCT03709082 TERMINATED
HER2-positive Breast Cancer; Breast Cancer Metastatic
University of Kansas Medical Center
2018-10-15 PHASE1; PHASE2
NCT01536743 COMPLETED
Ovarian Epithelial Carcinoma
Jonsson Comprehensive Cancer Center
2011-12-15 PHASE2
NCT03498378 ACTIVE_NOT_RECRUITING
Head and Neck Squamous Cell Carcinoma
Kathryn Gold
2018-06-06 PHASE1
NCT03123744 WITHDRAWN
Cancer, Advanced
Razelle Kurzrock, MD
2018-07-01 PHASE2
NCT02690480 UNKNOWN
Breast Neoplasms
Spanish Breast Cancer Research Group
2016-02-17 PHASE2
NCT02491983 COMPLETED
Metastatic Breast Cancer
MedSIR
2015-08 PHASE2
NCT03454919 UNKNOWN
Melanoma
Peking University Cancer Hospital & Institute
2018-03-30 PHASE2
NCT02692755 COMPLETED
Hormone Receptor Positive HER-2 Negative Breast Cancer
Georgetown University
2016-09 PHASE2; PHASE3
NCT03756090 UNKNOWN
Breast Cancer; Breast Diseases; Breast Neoplasms
Zhejiang Cancer Hospital
2018-12-01
NCT02530320 COMPLETED
Oligodendroglioma; Oligoastrocytoma
Grupo Español de Investigación en Neurooncología
2015-10-25 PHASE2
NCT03219554 UNKNOWN
Thymic Cancer
Samsung Medical Center
2017-08 PHASE2
NCT01037790 COMPLETED
Adult Solid Tumor; Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Adult Central Nervous System Germ Cell Tumor; Adult Teratoma; Benign Teratoma; Estrogen Receptor-negative Breast Cancer; Estrogen Receptor-positive Breast Cancer; Familial Testicular Germ Cell Tumor; HER2-negative Breast Cancer; HER2-positive Breast Cancer; Male Breast Cancer; Ovarian Immature Teratoma; Ovarian Mature Teratoma; Ovarian Monodermal and Highly Specialized Teratoma; Progesterone Receptor-negative Breast Cancer; Progesterone Receptor-positive Breast Cancer; Recurrent Breast Cancer; Recurrent Colon Cancer; Recurrent Extragonadal Germ Cell Tumor; Recurrent Extragonadal Non-seminomatous Germ Cell Tumor; Recurrent Extragonadal Seminoma; Recurrent Malignant Testicular Germ Cell Tumor; Recurrent Melanoma; Recurrent Ovarian Germ Cell Tumor; Recurrent Rectal Cancer; Stage III Extragonadal Non-seminomatous Germ Cell Tumor; Stage III Extragonadal Seminoma; Stage III Malignant Testicular Germ Cell Tumor; Stage III Ovarian Germ Cell Tumor; Stage IV Breast Cancer; Stage IV Colon Cancer; Stage IV Extragonadal Non-seminomatous Germ Cell Tumor; Stage IV Extragonadal Seminoma; Stage IV Melanoma; Stage IV Ovarian Germ Cell Tumor; Stage IV Rectal Cancer; Testicular Immature Teratoma; Testicular Mature Teratoma
Abramson Cancer Center at Penn Medicine
2009-10 PHASE2
NCT02530424 COMPLETED
Breast Neoplasms
Fondazione Michelangelo
2015-05 PHASE2
NCT02448771 COMPLETED
Breast Cancer Stage IV; Unresectable Locally Advanced Invasive Breast Cancer; Metastatic Invasive Breast Cancer
Dana-Farber Cancer Institute
2015-07-09 PHASE1; PHASE2
NCT03819010 COMPLETED
Breast Cancer
MedSIR
2019-05-07 PHASE2
NCT02679755 COMPLETED
Breast Cancer
Pfizer
2016-03-09 PHASE4
NCT02310243 UNKNOWN
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
University of Ulm
2015-07 PHASE1; PHASE2
NCT02600923 COMPLETED
Advanced Breast Cancer Female
Pfizer
2016-04-15 PHASE3
NCT01320592 COMPLETED
Breast Cancer
Abramson Cancer Center at Penn Medicine
2011-03 PHASE1
NCT03065621 COMPLETED
Breast Cancer Female
Jules Bordet Institute
2017-07-05 PHASE2
NCT02255461 TERMINATED
Childhood Choroid Plexus Tumor; Childhood Ependymoblastoma; Childhood Grade III Meningioma; Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Childhood Medulloepithelioma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Giant Cell Glioblastoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Gliomatosis Cerebri; Recurrent Childhood Gliosarcoma; Recurrent Childhood Medulloblastoma; Recurrent Childhood Pineoblastoma; Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
Pediatric Brain Tumor Consortium
2014-12-08 PHASE1
NCT02774681 TERMINATED
Breast Carcinoma Metastatic in the Brain; Estrogen Receptor Negative; HER2/Neu Negative; HER2/Neu Positive; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Stage IV Breast Cancer
Northwestern University
2016-08-31 PHASE2
NCT03194373 COMPLETED
Squamous Cell Carcinoma of the Head and Neck
University of Michigan Rogel Cancer Center
2017-10-12 PHASE2
NCT02592083 ACTIVE_NOT_RECRUITING
Early-Stage Breast Carcinoma; Hormone Receptor Positive Tumor
Thomas Hatschek
2015-10 PHASE2
NCT02028507 COMPLETED
Metastatic Breast Cancer
Spanish Breast Cancer Research Group
2014-03-13 PHASE3
NCT02389842 COMPLETED
Advanced Solid Tumours; Breast Cancer
Royal Marsden NHS Foundation Trust
2015-03-25 PHASE1
NCT02501902 COMPLETED
Metastatic Pancreatic Ductal Adenocarcinoma
Pfizer
2015-11-23 PHASE1
NCT02630693 COMPLETED
Breast Cancer
Canadian Cancer Trials Group
2016-04-08 PHASE2
NCT03377101 WITHDRAWN
Estrogen Receptor Positive; HER2/Neu Negative; Progesterone Receptor Positive; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2018-08-07 PHASE2
NCT02499146 COMPLETED
Advanced Breast Cancer
Pfizer
2015-09-11 PHASE1
NCT02499120 COMPLETED
Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Pfizer
2015-09-10 PHASE2
NCT02296801 COMPLETED
Breast Cancer; Breast Carcinoma; Breast Tumors
NSABP Foundation Inc
2015-01 PHASE2
NCT02159755 ACTIVE_NOT_RECRUITING
Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
2014-08-13 PHASE1
NCT02040857 COMPLETED
Breast Cancer
Dana-Farber Cancer Institute
2014-01 PHASE2
NCT02599714 COMPLETED
Advanced and Metastatic Breast Cancer
AstraZeneca
2015-12-07 PHASE1
NCT02400567 COMPLETED
Neoadjuvant Operable Breast Cancer
UNICANCER
2015-01 PHASE2
NCT02022982 COMPLETED
KRAS Mutant Non-Small Cell Lung Cancer; Solid Tumors
Dana-Farber Cancer Institute
2014-01 PHASE1
NCT02059213 COMPLETED
Prostate Cancer
University of Michigan Rogel Cancer Center
2014-06 PHASE2
NCT03220191 COMPLETED
Healthy Volunteer
Pfizer
2017-07-21 PHASE1
NCT02806648 COMPLETED
Pancreatic Neuroendocrine Cancer
Grupo Espanol de Tumores Neuroendocrinos
2015-05 PHASE2
NCT02785939 COMPLETED
CCND1 Gene Amplification; CCND2 Gene Amplification; CCND3 Gene Amplification; CDK4 Gene Amplification; Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC v7
SWOG Cancer Research Network
2014-09 PHASE2; PHASE3
NCT02549430 COMPLETED
Breast Cancer
Fondazione Sandro Pitigliani
2012-10 PHASE2
NCT02334527 TERMINATED
Metastatic Urothelial Carcinoma (UC)
UNC Lineberger Comprehensive Cancer Center
2015-03-17 PHASE2
NCT01907607 COMPLETED
Advanced Gastrointestinal Stromal Tumors
Institut Bergonié
2014-02 PHASE2
NCT02202200 UNKNOWN
Melanoma BRAF V600E/K Mutated; CDNKN2A Loss Defined
Assistance Publique - Hôpitaux de Paris
2014-05 PHASE1; PHASE2
NCT01209598 COMPLETED
Sarcoma; Liposarcoma
Memorial Sloan Kettering Cancer Center
2010-09-23 PHASE2
NCT02334800 COMPLETED
Healthy, Hepatic Insufficiency
Pfizer
2015-03-31 PHASE1
NCT02030483 TERMINATED
Multiple Myeloma
Weill Medical College of Cornell University
2014-02 PHASE1
NCT02065063 COMPLETED
Cancer
GlaxoSmithKline
2014-04-22 PHASE1
NCT02085538 COMPLETED
Renal Impairment
Pfizer
2014-05 PHASE1
NCT01684215 COMPLETED
Neoplasms; Breast Neoplasms
Pfizer
2012-10-19 PHASE2
NCT01740427 COMPLETED
Breast Neoplasms
Pfizer
2013-02-22 PHASE3
NCT02008734 COMPLETED
Untreated Operable Early Breast Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2014-01 PHASE2
NCT02311946 COMPLETED
Healthy
Pfizer
2015-01 PHASE1
NCT01942135 COMPLETED
Metastatic Breast Cancer
Pfizer
2013-09-26 PHASE3
NCT02222441 COMPLETED
Healthy
Pfizer
2014-10 PHASE1
NCT02097329 COMPLETED
Healthy
Pfizer
2014-04 PHASE1
NCT02059330 COMPLETED
Healthy
Pfizer
2014-03 PHASE1
NCT02131298 COMPLETED
Healthy
Pfizer
2014-05 PHASE1
NCT02083640 COMPLETED
Healthy
Pfizer
2014-03 PHASE1
NCT02041273 COMPLETED
Healthy
Pfizer
2014-01 PHASE1
NCT01291017 COMPLETED
Non-small Cell Lung Cancer
University of Florida
2011-02 PHASE2
NCT01953731 COMPLETED
Healthy
Pfizer
2013-10 PHASE1
NCT01906125 COMPLETED
Healthy
Pfizer
2013-09 PHASE1
NCT01227434 TERMINATED
Glioblastoma; Gliosarcoma; Anaplastic Astrocytoma
University of California, San Francisco
2010-09 PHASE2
NCT01918176 COMPLETED
Healthy
Pfizer
2013-09 PHASE1
NCT00721409 COMPLETED
Breast Cancer
Pfizer
2008-09-15 PHASE2
NCT01904747 COMPLETED
Healthy
Pfizer
2013-07 PHASE1
NCT01844323 COMPLETED
Healthy
Pfizer
2013-06 PHASE1
NCT01821066 COMPLETED
Healthy
Pfizer
2013-04 PHASE1
NCT01756781 COMPLETED
Healthy
Pfizer
2013-05 PHASE1
NCT01802476 COMPLETED
Healthy
Pfizer
2013-05 PHASE1
NCT01701375 TERMINATED
Relapsed Acute Leukemia; Refractory Acute Leukemia; High-Risk Myelodysplasia
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2012-09 PHASE1
NCT01756768 COMPLETED
Healthy
Pfizer
2013-01 PHASE1
NCT01111188 TERMINATED
Mantle Cell Lymphoma
Weill Medical College of Cornell University
2010-08-23 PHASE1
NCT01602887 COMPLETED
Healthy
Pfizer
2012-05 PHASE1
NCT00555906 COMPLETED
Multiple Myeloma
Pfizer
2008-01 PHASE2
NCT00420056 COMPLETED
Lymphoma, Mantle-Cell
Pfizer
2007-05 PHASE1
NCT00141297 COMPLETED
Neoplasms; Lymphoma, Non-Hodgkin
Pfizer
2004-09 PHASE1
NCT01709370 UNKNOWN
ER Positive, HER2 Negative Breast Cancer
Organisation for Oncology and Translational Research
2012-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2023-02-21)

Check the PD-0332991 (Palbociclib) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palbociclib selectively binds to and inhibits cyclin-dependent kinases 4 and 6 (CDK4/6), preventing the hyperphosphorylation of the retinoblastoma (Rb) protein and downregulating downstream E2F-mediated transcriptional programs. This targeted blockade suppresses Ki-67 proliferative markers to induce G1-phase cell cycle arrest, effectively inhibiting tumor growth in clinical indications such as hormone receptor-positive breast cancer and advanced solid neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.