Clinical Trials

Numerous clinical trials, ranging from Early Phase 1 to Phase 3, evaluate the efficacy and safety of talazoparib as monotherapy and in novel combinations with targeted agents or radionuclide therapy across indications such as metastatic breast cancer, metastatic castration-resistant prostate cancer, advanced solid neoplasms, neuroendocrine tumors, extensive-stage small cell lung carcinoma, and acute myeloid leukemia. Sponsored by pharmaceutical leaders like Pfizer alongside major academic institutions like the National Cancer Institute, these evaluations encompass recruitment statuses ranging from recruiting and active to completed, suspended, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05725200 RECRUITING
Metastatic Colorectal Cancer
Oslo University Hospital
 2022-09-27 PHASE2
NCT05071937 RECRUITING
Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
Alexander B Olawaiye, MD
 2023-04-21 PHASE2
NCT01042379 RECRUITING
Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
QuantumLeap Healthcare Collaborative
 2010-03-01 PHASE2
NCT06218628 RECRUITING
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Chronic Myelomonocytic Leukemia; Polycythemia Vera; Essential Thrombocytosis
Fox Chase Cancer Center
 2024-04-05 PHASE1
NCT05053854 RECRUITING
Neuroendocrine Tumors
Peter MacCallum Cancer Centre, Australia
 2021-12-08 PHASE1
NCT06844383 RECRUITING
Prostate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)
Prostate Cancer Clinical Trials Consortium
 2026-05-04 PHASE2
NCT04511039 RECRUITING
Advanced Malignant Solid Neoplasm; Clinical Stage III Gastroesophageal Junction Adenocarcinoma; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A; Locally Advanced Colorectal Carcinoma; Locally Advanced Gastroesophageal Junction Adenocarcinoma; Metastatic Colorectal Adenocarcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Stage III Colorectal Cancer AJCC v8; Stage IIIA Colorectal Cancer AJCC v8; Stage IIIB Colorectal Cancer AJCC v8; Stage IIIC Colorectal Cancer AJCC v8; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8
Roswell Park Cancer Institute
 2021-06-08 PHASE1
NCT05319249 NOT_YET_RECRUITING
Acute Myeloid Leukemia
German Cancer Research Center
 2024-06 PHASE1; PHASE2
NCT02693535 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
American Society of Clinical Oncology
 2016-03-14 PHASE2
NCT04693468 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2020-12-01 PHASE1
NCT05035745 RECRUITING
Advanced Refractory Solid Tumors; Advanced Triple Negative Breast Cancers; Metastatic Triple Negative Breast Cancers
National University Hospital, Singapore
 2021-03-01 PHASE1; PHASE2
NCT03968406 RECRUITING
Malignant Female Reproductive System Neoplasm; Recurrent Cervical Carcinoma; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Vaginal Carcinoma; Stage IV Cervical Cancer AJCC v8; 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 IV Vaginal Cancer AJCC v8; Stage IVA Cervical 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 IVA Vaginal Cancer AJCC v8; Stage IVB Cervical 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; Stage IVB Vaginal Cancer AJCC v8
M.D. Anderson Cancer Center
 2019-09-26 PHASE1
NCT04170946 RECRUITING
Lung Cancer; Small-Cell Lung Cancer
University Health Network, Toronto
 2020-10-05 PHASE1
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT04734730 RECRUITING
Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
City of Hope Medical Center
 2021-05-04 PHASE2
NCT04892693 RECRUITING
Advanced Breast Cancer
Seoul National University Hospital
 2021-05-25 PHASE2
NCT03964532 ACTIVE_NOT_RECRUITING
Breast Cancer
Georgetown University
 2019-04-17 PHASE1; PHASE2
NCT05101551 RECRUITING
Acute Myeloid Leukemia
Norman J. Lacayo
 2023-02-23 PHASE1
NCT03990896 RECRUITING
Breast Cancer
Massachusetts General Hospital
 2021-11-18 PHASE2
NCT04039230 ACTIVE_NOT_RECRUITING
Breast Cancer
Massachusetts General Hospital
 2019-10-09 PHASE1; PHASE2
NCT04901702 RECRUITING
Recurrent Solid Tumor; Recurrent Ewing Sarcoma; Recurrent Hepatoblastoma; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Rhabdoid Tumor; Recurrent Rhabdomyosarcoma; Recurrent Soft Tissue Sarcoma; Recurrent Wilms Tumor; Refractory Ewing Sarcoma; Refractory Hepatoblastoma; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Refractory Soft Tissue Sarcoma
St. Jude Children's Research Hospital
 2021-06-09 PHASE1; PHASE2
NCT05059522 ACTIVE_NOT_RECRUITING
Advanced Malignancies; NSCLC; Ovarian Cancer; Urothelial Cancer; Solid Tumors
Pfizer
 2021-09-29 PHASE3
NCT05327010 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2022-11-14 PHASE2
NCT05873192 RECRUITING
Prostate Cancer
M.D. Anderson Cancer Center
 2025-06-03 PHASE2
NCT02286687 ACTIVE_NOT_RECRUITING
Advanced Malignant Neoplasm; ATM Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; Metastatic Malignant Neoplasm; PALB2 Gene Mutation; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm
M.D. Anderson Cancer Center
 2014-12-22 PHASE2
NCT03672773 ACTIVE_NOT_RECRUITING
Recurrent Extensive Stage Small Cell Lung Carcinoma; Refractory Extensive Stage Small Cell Lung Carcinoma
Jonsson Comprehensive Cancer Center
 2018-10-31 PHASE2
NCT04486352 RECRUITING
Endometrial Cancer
Alliance Foundation Trials, LLC.
 2021-10-20 PHASE1; PHASE2
NCT04550494 ACTIVE_NOT_RECRUITING
Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Castration-Resistant Prostate Carcinoma; Clinical Stage III Gastric Cancer AJCC v8; Clinical Stage IV Gastric Cancer AJCC v8; HER2-Positive Breast Carcinoma; Locally Advanced Breast Carcinoma; Locally Advanced Gastric Carcinoma; Locally Advanced Malignant Solid Neoplasm; Locally Advanced Ovarian Carcinoma; Locally Advanced Pancreatic Carcinoma; Locally Advanced Prostate Carcinoma; Metastatic Breast Carcinoma; Metastatic Gastric Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Ovarian Carcinoma; Metastatic Pancreatic Carcinoma; Metastatic Prostate Carcinoma; Platinum-Sensitive Ovarian Carcinoma; Recurrent Breast Carcinoma; Recurrent Gastric Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8
National Cancer Institute (NCI)
 2021-04-26 PHASE2
NCT04821622 ACTIVE_NOT_RECRUITING
Prostate Cancer
Pfizer
 2021-05-12 PHASE3
NCT06582628 RECRUITING
Metastatic Prostate Cancer
Fundacion Oncosur
 2024-07-05 PHASE2
NCT04819243 RECRUITING
Premenopausal HR+/HER2- Metastatic Breast Cancer
Samsung Medical Center
 2021-08-25 PHASE2
NCT04991480 COMPLETED
Advanced Cancer; Metastatic Cancer; Breast Cancer
Artios Pharma Ltd
 2021-09-13 PHASE1
NCT04019327 TERMINATED
Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm; Prostate Cancer Metastatic; Castration-resistant Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2019-07-11 PHASE1; PHASE2
NCT06193525 RECRUITING
Advanced Breast Cancer
Erasmus Medical Center
 2019-09-16 PHASE2
NCT04334941 ACTIVE_NOT_RECRUITING
Extensive Stage Lung Small Cell Carcinoma
National Cancer Institute (NCI)
 2020-07-20 PHASE2
NCT05142241 ACTIVE_NOT_RECRUITING
Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2022-07-11 PHASE2
NCT04846478 ACTIVE_NOT_RECRUITING
Metastatic Prostate Cancer; Metastatic Castration-resistant Prostate Cancer
Dana-Farber Cancer Institute
 2021-06-28 PHASE1
NCT06762808 WITHDRAWN
Squamous Cell Carcinoma
M.D. Anderson Cancer Center
 2025-05-01 PHASE2
NCT04497116 COMPLETED
Advanced Solid Tumor
Repare Therapeutics
 2020-07-22 PHASE1; PHASE2
NCT04337970 COMPLETED
Kidney Cancer; Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma
Memorial Sloan Kettering Cancer Center
 2020-04-06 PHASE1; PHASE2
NCT04332744 COMPLETED
Metastatic Prostate Cancer
MedSIR
 2020-09-02 PHASE2
NCT03974217 ACTIVE_NOT_RECRUITING
Leukemia
Dana-Farber Cancer Institute
 2019-08-01 PHASE1
NCT04756765 WITHDRAWN
Breast Cancer; Advanced Breast Cancer
Stanford University
 2023-02-23 PHASE2
NCT04703920 COMPLETED
Metastatic Breast Cancer; Metastatic Castration-resistant Prostate Cancer; Metastatic Ovarian Carcinoma; Metastic or Unresectable Pancreatic Adenocarcinoma
University of Michigan Rogel Cancer Center
 2021-03-04 PHASE1
NCT04591431 UNKNOWN
Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer
Fondazione per la Medicina Personalizzata
 2020-10-07 PHASE2
NCT04849364 TERMINATED
Breast Cancer; Triple Negative Breast Cancer
Bryan Schneider, MD
 2021-08-24 PHASE2
NCT05425862 SUSPENDED
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Peter MacCallum Cancer Centre, Australia
 2022-10-21 PHASE1
NCT03911973 ACTIVE_NOT_RECRUITING
TNBC - Triple-Negative Breast Cancer
Kari Wisinski
 2019-04-17 PHASE1; PHASE2
NCT05097599 TERMINATED
Cancer; Advanced Solid Tumor
Strata Oncology
 2022-04-29 PHASE2
NCT05288127 UNKNOWN
HRD 100 Gene Expression High; Triple Negative Breast Cancer
University of Malaya
 2022-03-08 PHASE2
NCT04207190 COMPLETED
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
Roswell Park Cancer Institute
 2020-10-23 PHASE1
NCT03901469 TERMINATED
Triple Negative Breast Cancer
Zenith Epigenetics
 2019-06-26 PHASE2
NCT04755868 UNKNOWN
TNBC - Triple-Negative Breast Cancer
Yonsei University
 2021-03 PHASE2
NCT04134884 COMPLETED
Metastatic Breast Cancer; Triple Negative Breast Cancer; Hormone Receptor Positive Tumor
Kathy Miller
 2020-04-01 PHASE1
NCT04740190 COMPLETED
Recurrent Glioma; Recurrent Glioblastoma; Poly ADP Ribose Polymerase (PARP) Inhibitor; PTEN Gene Inactivation; IDH Mutation
The University of Hong Kong
 2021-01-01 PHASE2
NCT03426254 WITHDRAWN
Advanced or Recurrent Solid Tumors; Breast Neoplasm
Center Trials & Treatment
 2022-11-10 PHASE1
NCT04068831 COMPLETED
Metastatic Renal Cell Carcinoma; Fumarate Hydratase Deficient Renal Cell Carcinoma; Succinate Dehydrogenase Deficient Renal Cell Carcinoma
Memorial Sloan Kettering Cancer Center
 2019-08-22 PHASE2
NCT02912572 ACTIVE_NOT_RECRUITING
Metastatic Endometrial Cancer
Dana-Farber Cancer Institute
 2016-11-14 PHASE2
NCT04187833 COMPLETED
Metastatic or Unresectable Melanoma
Case Comprehensive Cancer Center
 2020-06-05 PHASE2
NCT04678362 RECRUITING
Urothelial Carcinoma
Centre Francois Baclesse
 2021-06-01 PHASE2
NCT04801966 TERMINATED
Cancer
Peter MacCallum Cancer Centre, Australia
 2021-09-23
NCT04598321 TERMINATED
BRCA1 Mutation; BRCA2 Mutation; Ovarian Cancer; Fallopian Tube Cancer; High Grade Serous Carcinoma
Brown University
 2021-03-29 PHASE1
NCT03395197 ACTIVE_NOT_RECRUITING
mCRPC
Pfizer
 2017-12-18 PHASE3
NCT05425862 Suspended
Metastatic Castration Resistant Prostate Cancer (mCRPC)
Peter MacCallum Cancer Centre Australia
 2022-10-21 Phase 1
NCT03565991 TERMINATED
Locally Advanced or Metastatic Solid Tumors; Genes, BRCA 1
Pfizer
 2018-06-18 PHASE2
NCT03330405 TERMINATED
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Pfizer
 2017-10-19 PHASE1; PHASE2
NCT04690855 TERMINATED
Breast Cancer; Triple Negative Breast Cancer
Mylin A. Torres, MD
 2021-10-04 PHASE2
NCT04672460 COMPLETED
Advanced Solid Tumors; Solid Tumors; Ovarian Cancer; Breast Cancer; Prostate Cancer; NSCLC; Pancreatic Cancer; Colorectal Cancer
Pfizer
 2020-12-21 PHASE1
NCT02316834 COMPLETED
Fallopian Tube Serous Adenocarcinoma; High Grade Ovarian Serous Adenocarcinoma; Ovarian Mass; Primary Peritoneal Serous Adenocarcinoma; Stage III Fallopian Tube Cancer AJCC v7; Stage III Ovarian Cancer AJCC v6 and v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7
M.D. Anderson Cancer Center
 2015-06-02 EARLY_PHASE1
NCT04824937 UNKNOWN
Prostate Cancer Metastatic
Massachusetts General Hospital
 2021-07 PHASE2
NCT03642132 TERMINATED
Ovarian Cancer
Pfizer
 2018-07-19 PHASE3
NCT05141708 Completed
Metastatic Breast Cancer|Breast Neoplasms
Pfizer
 2021-12-17 --
NCT05053854 Recruiting
Neuroendocrine Tumors
Peter MacCallum Cancer Centre Australia
 2021-12-08 Phase 1
NCT04173507 COMPLETED
Advanced Lung Non-Squamous Non-Small Cell Carcinoma; Recurrent Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
SWOG Cancer Research Network
 2020-02-14 PHASE2
NCT04991480 Active not recruiting
Advanced Cancer|Metastatic Cancer|Breast Cancer
Artios Pharma Ltd
 2021-09-13 Phase 1|Phase 2
NCT04635631 COMPLETED
Neoplasms
Pfizer
 2020-11-30 PHASE1
NCT04987931 Completed
Breast Cancer
Pfizer
 2021-08-20 --
NCT02921919 COMPLETED
Cancer
Pfizer
 2016-11-08 PHASE2
NCT04462809 UNKNOWN
Advanced Malignant Pleural or Peritoneal Mesothelioma
Hospices Civils de Lyon
 2020-09-01 PHASE2
NCT03343054 COMPLETED
Neoplasms; Breast Neoplasms
Pfizer
 2017-11-30 PHASE1
NCT03377556 COMPLETED
ATM Gene Mutation; ATR Gene Mutation; BARD1 Gene Mutation; BRCA1 Gene Mutation; BRCA2 Gene Mutation; BRIP1 Gene Mutation; CHEK1 Gene Mutation; CHEK2 Gene Mutation; FANCA Gene Mutation; FANCC Gene Mutation; FANCD2 Gene Mutation; FANCF Gene Mutation; FANCM Gene Mutation; NBN Gene Mutation; PALB2 Gene Mutation; RAD51 Gene Mutation; RAD51B Gene Mutation; RAD54L Gene Mutation; Recurrent Squamous Cell Lung Carcinoma; RPA1 Gene Mutation; Stage IV Squamous Cell Lung Carcinoma AJCC v7
SWOG Cancer Research Network
 2017-03-03 PHASE2
NCT03637491 TERMINATED
Pancreatic Cancer
Pfizer
 2018-08-15 PHASE1; PHASE2
NCT04052204 TERMINATED
Squamous Cell Carcinoma of the Head and Neck (SCCHN); Metastatic Castration Resistant Prostate Cancer (mCRPC)
Pfizer
 2019-12-30 PHASE1; PHASE2
NCT03499353 TERMINATED
Early Breast Cancer
Pfizer
 2018-08-27 PHASE2
NCT03148795 COMPLETED
Prostate Cancer
Pfizer
 2017-07-04 PHASE2
NCT03875313 TERMINATED
Solid Tumor; Clear Cell Renal Cell Carcinoma; TNBC - Triple-Negative Breast Cancer; Colorectal Cancer; CRC; RCC; ccRCC
Calithera Biosciences, Inc
 2019-05-20 PHASE1; PHASE2
NCT02836028 WITHDRAWN
Ovarian Cancer
Pfizer
 2016-10 PHASE2
NCT01989546 COMPLETED
Advanced Ovarian Cancer; Primary Peritoneal Cancer; Advanced Breast Cancer; Advanced Solid Tumors
National Cancer Institute (NCI)
 2014-02-04 PHASE1; PHASE2
NCT02997176 COMPLETED
Advanced Solid Tumors
Pfizer
 2016-09-30 PHASE1
NCT02878785 COMPLETED
Acute Myeloid Leukemia
University of Maryland, Baltimore
 2016-08 PHASE1; PHASE2
NCT02401347 COMPLETED
Advanced Breast Cancer; HER2/Neu Negative; Triple-Negative Breast Cancer
Melinda Telli
 2015-08 PHASE2
NCT02049593 COMPLETED
Metastatic Cancer; Unspecified Adult Solid Tumor
Jonsson Comprehensive Cancer Center
 2014-06-12 PHASE1
NCT02317874 COMPLETED
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
 2015-09-08 PHASE1
NCT02627430 WITHDRAWN
Adult Solid Neoplasm; Estrogen Receptor Negative; Fallopian Tube Serous Neoplasm; HER2/Neu Negative; Ovarian Serous Adenocarcinoma; Ovarian Serous Tumor; Primary Peritoneal Serous Adenocarcinoma; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Triple-Negative Breast Carcinoma
National Cancer Institute (NCI)
 2016-03 PHASE1
NCT02392793 COMPLETED
Childhood Solid Tumors
St. Jude Children's Research Hospital
 2015-03-25 PHASE1
NCT02997163 COMPLETED
Advanced Solid Tumors
Pfizer
 2017-02-21 PHASE1
NCT02358200 TERMINATED
Triple Negative Metastatic Breast Cancer; BRCA-mutated Solid Tumor
Pamela Munster
 2015-02-23 PHASE1
NCT02116777 COMPLETED
Adult Solid Neoplasm; Childhood Solid Neoplasm; Recurrent Childhood Central Nervous System Neoplasm; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Malignant Solid Neoplasm; Refractory Central Nervous System Neoplasm
National Cancer Institute (NCI)
 2014-05-16 PHASE1; PHASE2
NCT02567396 WITHDRAWN
Estrogen Receptor Negative; Head and Neck Squamous Cell Carcinoma; HER2/Neu Negative; Hormone-Resistant Prostate Cancer; Metastatic Pancreatic Adenocarcinoma; Progesterone Receptor Negative; Solid Neoplasm; Stage III Mesothelioma; Stage IIIA Gastric Cancer; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Small Cell Lung Carcinoma; Stage IIIB Gastric Cancer; Stage IIIB Non-Small Cell Lung Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Small Cell Lung Carcinoma; Stage IIIC Gastric Cancer; Stage IIIC Ovarian Cancer; Stage IV Mesothelioma; Stage IV Non-Small Cell Lung Cancer; Stage IV Ovarian Cancer; Stage IV Small Cell Lung Carcinoma; Triple-Negative Breast Carcinoma
National Cancer Institute (NCI)
 2016-06 PHASE1
NCT02537561 WITHDRAWN
Solid Tumors; Carcinoma, Non-Small Cell Lung; Non-Small Cell Lung Cancer; Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer
Washington University School of Medicine
 2015-12 PHASE1
NCT02282345 COMPLETED
Breast Adenocarcinoma; Deleterious BRCA1 Gene Mutation; Deleterious BRCA2 Gene Mutation; HER2/Neu Negative; Invasive Breast Carcinoma
M.D. Anderson Cancer Center
 2015-04-16 PHASE2
NCT03077607 COMPLETED
Advanced Solid Tumors
Pfizer
 2016-11-07 PHASE1
NCT01945775 COMPLETED
Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation
Pfizer
 2013-10-14 PHASE3
NCT03070548 COMPLETED
Advanced Solid Tumors
Pfizer
 2016-09 PHASE1
NCT03042910 COMPLETED
Solid Tumor
Pfizer
 2016-10-13 PHASE1
NCT02127151 WITHDRAWN
Endometrial Cancer
University College, London
 2014-10-01 PHASE2
NCT02034916 TERMINATED
Breast Neoplasms; BRCA 1 Gene Mutation; BRCA 2 Gene Mutation
Pfizer
 2013-12-13 PHASE2
NCT02326844 TERMINATED
Ovarian Cancer
National Cancer Institute (NCI)
 2015-03-02 PHASE2
NCT01286987 COMPLETED
Advanced or Recurrent Solid Tumors; Breast Neoplasms; Ovarian Cancer, Epithelial; Ewing Sarcoma; Small Cell Lung Carcinoma; Prostate Cancer; Pancreas Cancer
Pfizer
 2011-01-03 PHASE1
NCT01399840 COMPLETED
Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma
Pfizer
 2011-06-30 PHASE1
NCT01776437 COMPLETED
Human Volunteers
Pfizer
 2013-02 PHASE1

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

Check the BMN-673 (Talazoparib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Talazoparib potently binds to and inhibits poly(ADP-ribose) polymerase 1 (PARP1) and PARP2, thereby blocking single-strand DNA break repair and trapping PARP-DNA complexes. This molecular inhibition causes the accumulation of unrepairable double-strand DNA breaks during replication, driving targeted cell apoptosis in DNA repair-deficient malignancies such as metastatic breast cancer and metastatic castration-resistant prostate cancer.

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>).

Jump to

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