LEE011 (Ribociclib) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 590

Clinical Trials

Numerous clinical trials, ranging from Early Phase 1 through Phase 4, evaluate ribociclib as monotherapy or combined with endocrine agents, radiation, and immunotherapies across diverse indications, including HR+/HER2- breast cancer, pediatric and adult high-grade gliomas, glioblastomas, and epithelial ovarian cancer. Sponsored by industry leaders such as Novartis alongside academic centers like Dana-Farber Cancer Institute, these studies encompass recruitment statuses ranging from active recruitment and completed to terminated or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07237256	RECRUITING	Breast Cancer	UNICANCER	2025-12-18	PHASE3
NCT06849947	NOT_YET_RECRUITING	Breast Cancer Metastatic	Yeon Hee Park	2026-02-01	PHASE2
NCT02813135	RECRUITING	Pediatric Cancer	Gustave Roussy, Cancer Campus, Grand Paris	2016-08-03	PHASE1; PHASE2
NCT07423611	NOT_YET_RECRUITING	Breast Cancer	Fudan University	2026-10-01	PHASE2
NCT03424005	RECRUITING	Metastatic Breast Cancer	Hoffmann-La Roche	2018-03-30	PHASE1; PHASE2
NCT06953882	RECRUITING	HER2 Negative Breast Cancer	Yale University	2025-07-09	PHASE2
NCT05768139	RECRUITING	Breast Cancer; Solid Tumors, Adult	Eli Lilly and Company	2023-04-17	PHASE1; PHASE2
NCT05161195	ACTIVE_NOT_RECRUITING	Metastatic Breast Cancer	Novartis Pharmaceuticals	2022-07-07	PHASE4
NCT07708571	RECRUITING	HR+/HER2- Early Breast Cancer	Institut fuer Frauengesundheit	2025-11-04
NCT03701334	ACTIVE_NOT_RECRUITING	Early Breast Cancer	Novartis Pharmaceuticals	2018-12-07	PHASE3
NCT07400523	RECRUITING	Breast Cancer	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	2026-02-10	PHASE3
NCT06380751	RECRUITING	Advanced Breast Cancer	AstraZeneca	2024-08-01	PHASE3
NCT05296746	ACTIVE_NOT_RECRUITING	Breast Cancer Stage II	SOLTI Breast Cancer Research Group	2022-05-03	PHASE2
NCT05827081	RECRUITING	Early Breast Cancer	Novartis Pharmaceuticals	2024-02-28	PHASE3
NCT07164976	RECRUITING	Breast Cancer	Nagoya City University	2025-10-01	PHASE1; PHASE2
NCT07630948	NOT_YET_RECRUITING	Breast Cancer; Adherence, Medication	Institute of Oncology Ljubljana	2026-09-01	PHASE4
NCT05843253	RECRUITING	High Grade Glioma; Diffuse Intrinsic Pontine Glioma; Anaplastic Astrocytoma; Glioblastoma; Glioblastoma Multiforme; Diffuse Midline Glioma, H3 K27M-Mutant; Metastatic Brain Tumor; WHO Grade III Glioma; WHO Grade IV Glioma; Diffuse Hemispheric Glioma, H3 G34-Mutant	Nationwide Children's Hospital	2024-08-22	PHASE2
NCT07391774	RECRUITING	Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Anatomic Stage IIIC Breast Cancer AJCC v8; Estrogen Receptor-Positive Breast Carcinoma; HER2-Negative Breast Carcinoma	National Cancer Institute (NCI)	2026-08-10	PHASE3
NCT05203172	RECRUITING	Solid Tumors	Pfizer	2022-07-05	PHASE4
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
NCT07647328	RECRUITING	ER-Positive HER2-Negative Breast Cancer	AstraZeneca	2026-06-15	PHASE3
NCT07340658	NOT_YET_RECRUITING	Advanced, Metastatic Breast Cancer	Rovi Pharmaceuticals Laboratories	2026-08	PHASE3
NCT06760637	ACTIVE_NOT_RECRUITING	Breast Cancer	Pfizer	2025-01-06	PHASE3
NCT05816655	RECRUITING	Metastatic Breast Cancer	Korea University Guro Hospital	2023-05-31	PHASE2
NCT07405801	RECRUITING	Breast Cancer	Hoffmann-La Roche	2026-04-07	PHASE2
NCT07618390	NOT_YET_RECRUITING	Breast Cancer	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	2026-06	PHASE2
NCT07085767	RECRUITING	Breast Cancer; Locally Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma	Olema Pharmaceuticals, Inc.	2025-11-03	PHASE3
NCT05529862	ACTIVE_NOT_RECRUITING	Advanced or Metastatic Breast Cancer (BC)	Institut Paoli-Calmettes	2023-06-20
NCT06625775	RECRUITING	Solid Tumor, Adult; Metastatic Breast Cancer; Advanced Breast Cancer; HER2 Mutation-Related Tumors; HER2-positive Metastatic Breast Cancer; KRAS Mutant Metastatic Colorectal Cancer; Metastatic Lung Cancer; Metastatic Colorectal Cancer; Advanced Lung Cancer; HR-positive, HER2-negative Advanced Breast Cancer; HER2-positive Advanced Breast Cancer	TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)	2024-10-29	PHASE1
NCT07767474	NOT_YET_RECRUITING	Advanced Solid Tumors	Antares Therapeutics, Inc	2026-08-01	PHASE1; PHASE2
NCT06726148	RECRUITING	Advanced HR+/HER2- Breast Cancer; Advanced CCNE1-amplified Solid Tumors; Extensive-stage Small Cell Lung Cancer	Novartis Pharmaceuticals	2025-04-03	PHASE1; PHASE2
NCT06377852	RECRUITING	Metastatic Breast Cancer	American Society of Clinical Oncology	2024-10-29	PHASE3
NCT03008408	ACTIVE_NOT_RECRUITING	Recurrent Endometrial Carcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma; Refractory Endometrial Carcinoma; Refractory Endometrial Endometrioid Adenocarcinoma; Stage III Uterine Corpus Cancer AJCC v8; Stage IIIA Uterine Corpus Cancer AJCC v8; Stage IIIB Uterine Corpus Cancer AJCC v8; Stage IIIC Uterine Corpus Cancer AJCC v8; Stage IIIC1 Uterine Corpus Cancer AJCC v8; Stage IIIC2 Uterine Corpus Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8	M.D. Anderson Cancer Center	2017-08-18	PHASE2
NCT05467891	RECRUITING	Locoregional Recurrence; Hormone Receptor-positive Breast Cancer; HER2-negative Breast Cancer	Oana Danciu	2022-09-13	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
NCT05625087	ACTIVE_NOT_RECRUITING	Breast Cancer Stage IV	UNICANCER	2023-10-19	PHASE2
NCT07706933	NOT_YET_RECRUITING	Breast Cancer	Henan Cancer Hospital	2026-08-01
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
NCT07195227	RECRUITING	Hormon Receptor Positive Breast Cancer; Breast Cancer	MedSIR	2026-03-24	PHASE2
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
NCT07380646	RECRUITING	Leucogen; Ribociclib; Neutropenia (Low White Blood Cell Count); Breast Cancer	Second Affiliated Hospital, Zhejiang University, School of Medicine	2026-01-07	PHASE2
NCT05508906	RECRUITING	Metastatic Breast Cancer; ER-positive Breast Cancer; HER2-negative Breast Cancer; Breast Cancer; Locally Advanced Breast Cancer	Olema Pharmaceuticals, Inc.	2022-08-31	PHASE1
NCT05683418	RECRUITING	HR+/HER2-negative Breast Cancer	Totus Medicines	2023-02-15	PHASE1
NCT04862663	ACTIVE_NOT_RECRUITING	Locally Advanced (Inoperable) or Metastatic Breast Cancer	AstraZeneca	2021-05-10	PHASE3
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT06188520	RECRUITING	ER+ HER2- Advanced Breast Cancer; High-grade Serous Ovarian Cancer (HGSOC)	AstraZeneca	2023-12-05	PHASE1; PHASE2
NCT04055493	ACTIVE_NOT_RECRUITING	Breast Cancer Female	Women's Cancer Study Group GmbH	2019-07-02	PHASE3
NCT07054190	RECRUITING	Breast Cancer	Hoffmann-La Roche	2025-09-09	PHASE2
NCT05238922	ACTIVE_NOT_RECRUITING	Solid Tumors	Incyte Corporation	2022-07-05	PHASE1
NCT05900206	RECRUITING	Breast Cancer	Karolinska University Hospital	2023-10-26	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
NCT05319873	ACTIVE_NOT_RECRUITING	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; Invasive Breast Carcinoma; Locally Advanced HER2-Positive Breast Carcinoma; Metastatic HER2-Positive Breast Carcinoma; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage II 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	Jonsson Comprehensive Cancer Center	2022-04-07	PHASE1; PHASE2
NCT06409390	RECRUITING	Metastatic Breast Cancer	H. Lee Moffitt Cancer Center and Research Institute	2024-08-14	PHASE2
NCT05691400	WITHDRAWN	CYP3A4*22	University of Michigan Rogel Cancer Center	2024-03	PHASE4
NCT06065748	RECRUITING	Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer	Hoffmann-La Roche	2023-12-11	PHASE3
NCT04417621	ACTIVE_NOT_RECRUITING	Melanoma	Novartis Pharmaceuticals	2020-10-30	PHASE2
NCT02934568	ACTIVE_NOT_RECRUITING	Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies	Novartis Pharmaceuticals	2016-12-15	PHASE2
NCT06481956	ENROLLING_BY_INVITATION	HER2-positive Advanced Breast Cancer	Zheng Yabing	2023-10-25	PHASE2
NCT06239467	ACTIVE_NOT_RECRUITING	Advanced Cancer; Breast Cancer; Advanced Solid Tumors; PI3K Gene Mutation	OnKure, Inc.	2024-02-26	PHASE1
NCT05870579	ACTIVE_NOT_RECRUITING	Breast Cancer	Novartis Pharmaceuticals	2023-11-13	PHASE1
NCT05573555	ACTIVE_NOT_RECRUITING	Breast Cancer	Pfizer	2023-03-01	PHASE1; PHASE2
NCT05563220	ACTIVE_NOT_RECRUITING	Breast Cancer; Metastatic Breast Cancer	Stemline Therapeutics, Inc.	2023-01-24	PHASE1; PHASE2
NCT03114527	ACTIVE_NOT_RECRUITING	Soft Tissue Sarcoma	Fox Chase Cancer Center	2017-08-08	PHASE2
NCT02608216	ACTIVE_NOT_RECRUITING	Breast Neoplasm; Metastatic Breast Cancer; Rb+ Breast Cancer	University of Pennsylvania	2015-11	PHASE1
NCT03333343	ACTIVE_NOT_RECRUITING	EGFR-mutant Non-small Cell Lung Cancer	Novartis Pharmaceuticals	2018-01-29	PHASE1
NCT04116541	RECRUITING	Malignant Solid Tumor	Centre Leon Berard	2020-01-28	PHASE2
NCT03090165	ACTIVE_NOT_RECRUITING	Triple Negative Breast Cancer	Kari Wisinski	2018-05-07	PHASE1; PHASE2
NCT05996107	RECRUITING	Breast Cancer	University of Michigan Rogel Cancer Center	2024-02-27	PHASE1
NCT05358249	ACTIVE_NOT_RECRUITING	KRAS G12C Mutant Solid Tumors; Carcinoma, Non-Small Cell Lung; Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Colorectal Cancer; Colorectal Carcinoma; Colorectal Neoplasms; Colorectal Tumors; Neoplasms, Colorectal	Novartis Pharmaceuticals	2022-10-24	PHASE1; PHASE2
NCT06959979	RECRUITING	Medulloblastoma, Childhood	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	2024-11-25	EARLY_PHASE1
NCT06375707	COMPLETED	Advanced Breast Cancer	The First Affiliated Hospital with Nanjing Medical University	2024-01-09	PHASE2
NCT03285412	ACTIVE_NOT_RECRUITING	Breast Cancer	Massachusetts General Hospital	2017-12-12	PHASE2
NCT05664893	WITHDRAWN	HER2 Negative Breast Cancer Not Immediately Operated	Centre Antoine Lacassagne	2023-06-26	PHASE1; PHASE2
NCT05207709	TERMINATED	Metastatic Breast Cancer	SOLTI Breast Cancer Research Group	2022-03-28	PHASE3
NCT06585969	WITHDRAWN	Metastatic Breast Cancer; ER-positive Breast Cancer; Luminal B; Her2 Enriched; Basal Like	Danish Breast Cancer Cooperative Group	2026-01-01	PHASE3
NCT06656624	RECRUITING	Advanced Breast Cancer	The First Affiliated Hospital with Nanjing Medical University	2024-08-13	PHASE2
NCT06810492	NOT_YET_RECRUITING	Breast Cancer Stage III; Breast Cancer Stage II	Hongmei Zheng, PhD	2025-04-01
NCT03081234	WITHDRAWN	Breast Cancer	Novartis Pharmaceuticals	2018-03-31	PHASE3
NCT07487129	COMPLETED	Breast Cancer	Beni-Suef University	2024-08-25	PHASE4
NCT05766410	RECRUITING	Breast Cancer; Hormone Receptor-positive Breast Cancer; Hormone Therapy	National Taiwan University Hospital	2022-09-16	PHASE2
NCT05252416	TERMINATED	Advanced Solid Tumors; HR+ Breast Cancer; CCNE1 Amplification; HER2-negative Breast Cancer; Ovarian Cancer; Endometrial Cancer; Gastric Cancer; Esophageal Adenocarcinoma; Carcinosarcoma	Blueprint Medicines Corporation	2022-04-07	PHASE1
NCT04964934	ACTIVE_NOT_RECRUITING	ER-Positive HER2-Negative Breast Cancer	AstraZeneca	2021-06-30	PHASE3
NCT06344416	UNKNOWN	Any Solid Oral Medication	Dosentrx Ltd.	2024-03-30
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
NCT05429502	TERMINATED	Neuroblastoma	Novartis Pharmaceuticals	2022-12-27	PHASE1
NCT02344472	UNKNOWN	Metastatic Breast Cancer	Prof. Wolfgang Janni	2015-09	PHASE3
NCT03944434	ACTIVE_NOT_RECRUITING	Breast Cancer	Fondazione Sandro Pitigliani	2018-12-27	PHASE2
NCT03673124	ACTIVE_NOT_RECRUITING	Low Grade Serous Carcinoma	Gynecologic Oncology Group	2019-05-20	PHASE2
NCT05452213	RECRUITING	Breast Cancer; Breast Neoplasms; Breast Neoplasm Female; Breast Cancer Female; HER2-negative Breast Cancer; Hormone Receptor-positive Breast Cancer; Advanced Breast Cancer	Institut fuer Frauengesundheit	2022-10-12	PHASE4
NCT03616587	ACTIVE_NOT_RECRUITING	ER+ HER2- Advanced Breast Cancer	AstraZeneca	2018-10-11	PHASE1
NCT05163106	COMPLETED	Breast Cancer; HER2-negative Breast Cancer; ER-positive Breast Cancer; Locally Advanced Breast Cancer; Luminal A Breast Cancer; Luminal B Breast Cancer	University Hospital, Akershus	2022-12-01	PHASE2
NCT05843253	Not yet recruiting	High Grade Glioma\|Diffuse Intrinsic Pontine Glioma\|Anaplastic Astrocytoma\|Glioblastoma\|Glioblastoma Multiforme\|Diffuse Midline Glioma H3 K27M-Mutant\|Metastatic Brain Tumor\|WHO Grade III Glioma\|WHO Grade IV Glioma	Nationwide Children''s Hospital\|Novartis	2024-05-30	Phase 2
NCT05384119	TERMINATED	Breast Cancer	Tvardi Therapeutics, Incorporated	2023-01-09	PHASE1
NCT02974725	TERMINATED	Non-Small Cell Lung Cancer; Melanoma	Novartis Pharmaceuticals	2017-02-24	PHASE1
NCT04315233	TERMINATED	Metastatic Breast Cancer; Recurrent Ovarian Carcinoma	University of Utah	2021-05-03	PHASE1
NCT06075758	Recruiting	Breast Cancer	Novartis Pharmaceuticals\|Novartis	2024-03-07	--
NCT05996107	Recruiting	Breast Cancer	University of Michigan Rogel Cancer Center	2024-02-27	Phase 1
NCT04000529	TERMINATED	Non-small Cell Lung Carcinoma; Head and Neck Squamous Cell Carcinoma; Esophageal SCC; Gastrointestinal Stromal Tumors; Colorectal Cancer	Novartis Pharmaceuticals	2019-07-30	PHASE1
NCT02035813	COMPLETED	HER2-negative and Hormone-receptor Positive Metastatic Breast Cancer; HER2-negative Circulating Tumor Cells; Postmenopausal Female Patients	Prof. Wolfgang Janni	2014-01	PHASE2
NCT04213404	UNKNOWN	Head and Neck Squamous Cell Carcinoma	National Taiwan University Hospital	2020-03-13	PHASE1
NCT03439046	TERMINATED	Breast Cancer	Novartis Pharmaceuticals	2018-02-02	PHASE3
NCT04657679	TERMINATED	Breast Cancer	Georgetown University	2021-05-20	PHASE4
NCT03913234	UNKNOWN	HER2-positive Breast Cancer; Postmenopausal; Metastatic Breast Cancer	Yonsei University	2019-06-10	PHASE1; PHASE2
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
NCT03740334	ACTIVE_NOT_RECRUITING	Acute Lymphoblastic Leukemia ALL	Dana-Farber Cancer Institute	2019-01-30	PHASE1
NCT02933736	ACTIVE_NOT_RECRUITING	Glioblastoma Multiforme; Meningioma	Nader Sanai	2016-10-17	EARLY_PHASE1
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
NCT04801966	TERMINATED	Cancer	Peter MacCallum Cancer Centre, Australia	2021-09-23
NCT02555189	TERMINATED	Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Carcinoma Metastatic in the Bone; Stage IV Prostate Cancer AJCC v7	Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University	2015-12-01	PHASE1; PHASE2
NCT03283384	ACTIVE_NOT_RECRUITING	Breast Neoplasms	Borstkanker Onderzoek Groep	2019-06-15	PHASE2
NCT03434262	COMPLETED	Anaplastic Astrocytoma; Anaplastic Ependymoma; Anaplastic Ganglioglioma; Anaplastic Meningioma; Anaplastic Oligodendroglioma; Pleomorphic Xanthoastrocytoma, Anaplastic; Atypical Teratoid/Rhabdoid Tumor; Brain Cancer; Brain Tumor; Central Nervous System Neoplasms; Choroid Plexus Carcinoma; CNS Embryonal Tumor With Rhabdoid Features; Ganglioneuroblastoma of Central Nervous System; CNS Tumor; Embryonal Tumor of CNS; Ependymoma; Glioblastoma; Glioma; Glioma, Malignant; Medulloblastoma; Medulloblastoma; Unspecified Site; Medulloepithelioma; Neuroepithelial Tumor; Neoplasms; Neoplasms, Neuroepithelial; Papillary Tumor of the Pineal Region (High-grade Only); Pediatric Brain Tumor; Pineal Parenchymal Tumor of Intermediate Differentiation (High-grade Only); Pineoblastoma; Primitive Neuroectodermal Tumor; Recurrent Medulloblastoma; Refractory Brain Tumor; Neuroblastoma. CNS; Glioblastoma, IDH-mutant; Glioblastoma, IDH-wildtype; Medulloblastoma, Group 3; Medulloblastoma, Group 4; Glioma, High Grade; Neuroepithelial Tumor, High Grade; Medulloblastoma, SHH-activated and TP53 Mutant; Medulloblastoma, SHH-activated and TP53 Wildtype; Medulloblastoma, Chromosome 9q Loss; Medulloblastoma, Non-WNT Non-SHH, NOS; Medulloblastoma, Non-WNT/Non-SHH; Medulloblastoma, PTCH1 Mutation; Medulloblastoma, WNT-activated; Ependymoma, Recurrent; Glioma, Recurrent High Grade; Glioma, Recurrent Malignant; Embryonal Tumor, NOS; Glioma, Diffuse Midline, H3K27M-mutant; Embryonal Tumor With Multilayered Rosettes (ETMR); Ependymoma, NOS, WHO Grade III; Ependymoma, NOS, WHO Grade II; Medulloblastoma, G3/G4; Ependymoma, RELA Fusion Positive	St. Jude Children's Research Hospital	2018-03-05	PHASE1
NCT02780128	TERMINATED	Neuroblastoma; Cancer	Yael P Mosse	2016-07	PHASE1
NCT03555877	COMPLETED	Breast Cancer Metastatic	GBG Forschungs GmbH	2018-03-15	PHASE2
NCT03237390	COMPLETED	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm	Mayo Clinic	2018-01-04	PHASE1
NCT03671330	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2018-08-29	PHASE2
NCT03839823	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2019-02-25	PHASE2
NCT02754011	COMPLETED	Breast Cancer	UNICANCER	2017-02-02	PHASE1
NCT03834740	COMPLETED	Glioblastoma Multiforme; Glioma of Brain	St. Joseph's Hospital and Medical Center, Phoenix	2019-01-19	EARLY_PHASE1
NCT02632045	COMPLETED	Metastatic Breast Cancer; Breast Carcinoma	Melissa K Accordino	2016-03	PHASE2
NCT03462251	COMPLETED	Breast Cancer; Hormone Receptor Positive Tumor; HER 2 Negative Breast Cancer	iOMEDICO AG	2018-05-24	PHASE3
NCT03477396	COMPLETED	Estrogen Receptor and/or Progesterone Receptor Positive; HER2/Neu Negative; Stage IV Breast Cancer AJCC v6 and v7	City of Hope Medical Center	2018-06-14	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
NCT02494921	COMPLETED	Prostate Cancer	Rahul Aggarwal	2015-11-20	PHASE1; PHASE2
NCT03822468	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2019-06-11	PHASE2
NCT03905343	TERMINATED	Breast Cancer	Swiss Cancer Institute	2019-06-25	PHASE3
NCT03294694	TERMINATED	Metastatic Hormone-Receptor-Positive (HR+) Breast Cancer; HER2-Negative Breast Cancer; Metastatic Epithelial Ovarian Cancer	Dana-Farber Cancer Institute	2017-11-08	PHASE1
NCT02657343	COMPLETED	Breast Cancer	Dana-Farber Cancer Institute	2016-03-09	PHASE1; PHASE2
NCT03355794	COMPLETED	Diffuse Intrinsic Pontine Glioma; Malignant Glioma of Brain; High Grade Glioma; Bithalamic High Grade Glioma; Brainstem Glioma; Glioblastoma; Anaplastic Astrocytoma	Children's Hospital Medical Center, Cincinnati	2017-11-14	PHASE1
NCT03056833	COMPLETED	Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Carcinoma	Ronald Buckanovich	2017-06-10	PHASE1
NCT03387020	COMPLETED	CNS Embryonal Tumor, Not Otherwise Specified; Malignant Glioma; Recurrent Atypical Teratoid/Rhabdoid Tumor; Recurrent Childhood Ependymoma; Recurrent Diffuse Intrinsic Pontine Glioma; Recurrent Medulloblastoma; Refractory Diffuse Intrinsic Pontine Glioma	Pediatric Brain Tumor Consortium	2018-01-13	PHASE1
NCT03078751	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2017-06-20	PHASE2
NCT02732119	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2016-06-14	PHASE1; PHASE2
NCT03096912	UNKNOWN	Liposarcomas, Dedifferentiated; Liposarcoma - Well Differentiated; Liposarcoma; Mixed Type; Soft-Tissue Sarcoma	Assaf-Harofeh Medical Center	2016-07	PHASE2
NCT02941926	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2016-11-30	PHASE3
NCT03009201	COMPLETED	Advanced Soft Tissue Sarcoma; Locally Advanced Angiosarcoma; Locally Advanced Leiomyosarcoma; Locally Advanced Liposarcoma; Locally Advanced Malignant Peripheral Nerve Sheath Tumor; Locally Advanced Myxofibrosarcoma; Locally Advanced Undifferentiated Pleomorphic Sarcoma; Metastatic Angiosarcoma; Metastatic Epithelioid Sarcoma; Metastatic Fibrosarcoma; Metastatic Liposarcoma; Metastatic Malignant Peripheral Nerve Sheath Tumor; Metastatic Myxofibrosarcoma; Metastatic Soft Tissue Sarcoma; Metastatic Synovial Sarcoma; Metastatic Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma; Pleomorphic Rhabdomyosarcoma; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Undifferentiated (Embryonal) Sarcoma; Unresectable Leiomyosarcoma; Unresectable Liposarcoma; Unresectable Malignant Peripheral Nerve Sheath Tumor; Unresectable Soft Tissue Sarcoma; Unresectable Synovial Sarcoma; Unresectable Undifferentiated Pleomorphic Sarcoma	OHSU Knight Cancer Institute	2017-03-10	PHASE1
NCT02703571	TERMINATED	Solid Tumors for Phase Ib; Pancreatic Cancer for Phase II; Colorectal Cancer for Phase II	Novartis Pharmaceuticals	2016-06-29	PHASE1
NCT02345824	UNKNOWN	Glioblastoma; Glioma	University of Virginia	2016-03	PHASE1
NCT03248427	COMPLETED	Breast Cancer	SOLTI Breast Cancer Research Group	2017-07-13	PHASE2
NCT02420691	COMPLETED	Advanced Digestive System Neuroendocrine Neoplasm; Duodenal Neuroendocrine Tumor G1; Functional Pancreatic Neuroendocrine Tumor; Gastric Neuroendocrine Tumor; Intermediate Grade Lung Neuroendocrine Neoplasm; Low Grade Lung Neuroendocrine Neoplasm; Nonfunctional Pancreatic Neuroendocrine Tumor; Thymus Neoplasm	M.D. Anderson Cancer Center	2015-08-25	PHASE2
NCT02599363	COMPLETED	Advanced Breast Cancer	Abramson Cancer Center at Penn Medicine	2016-01	PHASE1
NCT03050398	TERMINATED	Breast Cancer	Novartis Pharmaceuticals	2017-06-07	PHASE3
NCT03096847	COMPLETED	Advanced Metastatic Breast Cancer	Novartis Pharmaceuticals	2016-10-24	PHASE3
NCT03179956	TERMINATED	Squamous Cell Carcinoma of the Head and Neck	Fox Chase Cancer Center	2018-04-02	EARLY_PHASE1
NCT02292550	COMPLETED	Non-small Cell Lung Cancer	Novartis Pharmaceuticals	2015-05-14	PHASE1
NCT02712723	ACTIVE_NOT_RECRUITING	Breast Cancer	Qamar Khan	2016-02	PHASE2
NCT02657928	COMPLETED	Estrogen Receptor Positive; Postmenopausal; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Uterine Corpus Carcinoma	Mayo Clinic	2016-07-08	PHASE2
NCT02607124	TERMINATED	High Grade Glioma; Diffuse Intrinsic Pontine Glioma; Bithalamic High Grade Glioma	Children's Hospital Medical Center, Cincinnati	2016-04	PHASE1; PHASE2
NCT01857193	COMPLETED	Breast Cancer	Novartis Pharmaceuticals	2013-09-06	PHASE1
NCT02422615	COMPLETED	Advanced Breast Cancer	Novartis Pharmaceuticals	2015-06-09	PHASE3
NCT02278120	COMPLETED	Advanced Metastatic Breast Cancer	Novartis Pharmaceuticals	2014-11-20	PHASE3
NCT02571829	UNKNOWN	Liposarcoma; Soft Tissue Sarcoma	Hadassah Medical Organization	2016-05	PHASE2
NCT02586675	COMPLETED	Breast Cancer; Breast Cancer - Female; Breast Cancer - Male	H. Lee Moffitt Cancer Center and Research Institute	2016-02-23	PHASE1
NCT02414724	TERMINATED	Lymphoma; Solid Neoplasm	Roswell Park Cancer Institute	2015-05	PHASE1
NCT01958021	COMPLETED	Advanced, Metastatic Breast Cancer	Novartis Pharmaceuticals	2013-12-17	PHASE3
NCT01919229	TERMINATED	Early Breast Cancer	Novartis Pharmaceuticals	2013-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-26)

Check the LEE011 (Ribociclib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ribociclib acts as a potent and selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) with IC50 values of 10 nM and 39 nM, respectively, preventing the formation of active CDK4/6-cyclin D complexes. By blocking CDK4/6-mediated phosphorylation of the retinoblastoma protein, this agent arrests cell cycle progression at the G1/S phase transition, ultimately suppressing cell proliferation in clinical indications such as hormone receptor-positive, HER2-negative breast cancer and high-grade gliomas.

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>).