51 completed. 51 Phase 1, 12 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 51 | Completed 51 |
| Phase 2 | 12 | Completed 12 |
Follow palbociclib: new trials by email Literature Review of palbociclib trials Research Report on palbociclib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors RLY-5836, Fulvestrant, Palbociclib - PIK3CA Mutation, Solid Tumor, Adult | Phase 1 | Completed | Relay Therapeutics, Inc. | 41 | 2023-03-29 | 2025-05-16 |
| Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16) MRTX849, Palbociclib - Advanced Solid Tumor | Phase 1 | Completed | Mirati Therapeutics Inc. | 11 | 2022-01-20 | 2025-02-11 |
| AZD9833 China PK Study AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus - ER+, HER2-, Metastatic Breast Cancer | Phase 1 | Completed | AstraZeneca | 28 | 2021-11-12 | 2024-12-17 |
| ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer ONO-4578, letrozole, Palbociclib - Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer | Phase 1 | Completed | Ono Pharmaceutical Co., Ltd. | 46 | 2021-11-09 | 2026-06-05 |
| A Study of ERAS-007 in Patients With Advanced Gastrointestinal Malignancies ERAS-007, Encorafenib, Cetuximab - Metastatic Colorectal Cancer, Metastatic Pancreatic Ductal Adenocarcinoma | Phase 1 / Phase 2 | Completed | Erasca, Inc. | 101 | 2021-09-20 | 2026-03-25 |
| Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia Palbociclib, Dexamethasone, Bortezomib - Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia | Phase 1 | Completed | Tanja Andrea Gruber | 2 | 2021-07-09 | 2026-04-17 |
| Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. Combination, Rogaratinib + palbociclib + fulvestrant - Breast Cancer Metastatic, Hormone Receptor Positive Malignant Neoplasm of Breast | Phase 1 | Completed | Fundacion CRIS de Investigación para Vencer el Cáncer | 9 | 2020-11-25 | 2023-12-28 |
| Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer Combination, Palbociclib + Binimetinib - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Completed | Fundacion Oncosur | 24 | 2020-11-18 | 2025-03-24 |
| HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer Palbociclib, Olaparib, Fulvestrant - Metastatic Breast Cancer, Locally Advanced Breast Cancer | Phase 1 | Completed | Abramson Cancer Center at Penn Medicine | 9 | 2020-10-15 | 2026-01-09 |
| Palbociclib, Letrozole & Venetoclax in ER and BCL-2 Positive Breast Cancer Venetoclax, Palbociclib, Letrozole - Breast Neoplasm Female | Phase 1 | Completed | Peter MacCallum Cancer Centre, Australia | 17 | 2019-09-25 | 2026-11-02 |
| A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer Vepdegestrant, Palbociclib - Breast Cancer | Phase 1 / Phase 2 | Completed | Arvinas Estrogen Receptor, Inc. | 219 | 2019-09-22 | 2026-09-29 |
| A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors Telaglenestat (CB-839), Palbociclib Oral Capsule or Tablet [Ibrance] - Solid Tumors, NSCLC | Phase 1 / Phase 2 | Completed | Calithera Biosciences, Inc | 53 | 2019-06-25 | 2022-09-19 |
| Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia Palcociclib, CPX-351 - Acute Myeloid Leukemia, AML | Phase 1 / Phase 2 | Completed | Sudipto Mukherjee, MD, PhD, MPH | 35 | 2019-06-06 | 2025-05-31 |
| Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Palbociclib, Cytarabine, Methotrexate - Leukemia, Lymphocytic, Lymphoblastic Lymphoma | Phase 1 | Completed | Children's Oncology Group | 12 | 2019-04-11 | 2025-03-21 |
| WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor Palbociclib, Bosutinib, Fulvestrant - Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | Phase 1 | Completed | Georgetown University | 19 | 2019-04-01 | 2025-02-06 |
| A Study of ZN-c5 in Subjects With Breast Cancer ZN-c5, Palbociclib - Breast Cancer | Phase 1 / Phase 2 | Completed | Zeno Alpha Inc. | 181 | 2018-11-30 | 2024-08-09 |
| Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer Hydroxychloroquine, Letrozole, Palbociclib - Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8 | Phase 1 / Phase 2 | Completed | M.D. Anderson Cancer Center | 15 | 2018-08-20 | 2025-02-17 |
| G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer G1T48, Palbociclib - Carcinoma, Ductal, Breast, Breast Cancer Female | Phase 1 | Completed | G1 Therapeutics, Inc. | 107 | 2018-05-09 | 2026-09-21 |
| Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia Palbociclib, Dexamethasone - Recurrent B Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia | Phase 1 | Completed | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | 7 | 2018-05-09 | 2025-05-15 |
| NCT Neuro Master Match - N²M² (NOA-20) APG101, Alectinib, Idasanutlin - Glioblastoma, Adult | Phase 1 / Phase 2 | Completed | University Hospital Heidelberg | 228 | 2018-05-07 | 2023-09-28 |
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Breast Neoplasms (19) · Colorectal Neoplasms (2) · Neoplasm Metastasis (2) · Neoplasms (2) · Pancreatic Neoplasms (2) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (2) · Recurrence (2) · Burkitt Lymphoma (1) · Carcinoma, Ductal, Breast (1) · Carcinoma, Non-Small-Cell Lung (1) · Digestive System Neoplasms (1) · Gastrointestinal Neoplasms (1) · Glioblastoma (1) · Head and Neck Neoplasms (1) · Hepatic Insufficiency (1)
Pfizer (16) · Dana-Farber Cancer Institute (4) · Abramson Cancer Center at Penn Medicine (2) · AstraZeneca (2) · Arvinas Estrogen Receptor, Inc. (1) · Calithera Biosciences, Inc (1) · Celcuity Inc (1) · Children's Oncology Group (1) · Emory University (1) · Erasca, Inc. (1) · Fundacion CRIS de Investigación para Vencer el Cáncer (1) · Fundacion Oncosur (1) · G1 Therapeutics, Inc. (1) · Georgetown University (1) · GlaxoSmithKline (1)
United States (43) · China (3) · Spain (3) · Ukraine (2) · United Kingdom (2) · Australia (1) · Belarus (1) · Belgium (1) · Bosnia and Herzegovina (1) · Bulgaria (1) · Czechia (1) · Georgia (1) · Germany (1) · Hungary (1) · Japan (1)
Anja Wiliams (1) · Barbara Haley, MD (1) · Brent Rexer, MD, PhD (1) · Claudine Isaacs, MD (1) · Debasish Tripathy (1) · Douglas Adkins, M.D. (1) · Elena Shagisultanova, MD, PhD (1) · Elizabeth Raetz, MD (1) · Emil Kuriakose, MD (1) · Geoffrey Lindeman, MBBS FRACP PhD (1) · Geoffrey Shapiro, MD, PhD (1)
PMID 19164198, PMID 19238148, PMID 22383795, PMID 30635336, PMID 31351869, PMID 32958578, PMID 33835229, PMID 34554584, PMID 34728571, PMID 35187951, PMID 35235412, PMID 35405009, PMID 36215125, PMID 36970055, PMID 37363965, PMID 37553297, PMID 38547892, PMID 39865083, PMID 40627530, PMID 40913172, PMID 40928353, PMID 40973049
2015 (3), 2014 (1), 2017 (1), P30CA138292 (1)