51 completed, 19 active not recruiting, 18 recruiting, 15 terminated. 121 Phase 1, 41 Phase 2.
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 |
|---|---|---|---|---|---|---|
| A Phase 1/2a Study of K-1728 in Advanced Solid Tumors K-1728, Fulvestrant, Palbociclib - Breast Neoplasms, Solid Tumors | Phase 1 / Phase 2 | Not yet recruiting | KymaThera, Inc. | 110 | 2026-10-01 | 2026-10-06 |
| A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors LAE118, Fulvestrant, Palbociclib - Patients With Advanced Solid Tumors | Phase 1 | Not yet recruiting | Laekna Limited | 150 | 2026-08-01 | 2026-08-26 |
| A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma Palbociclib, Afatinib(30mg), Afatinib(40mg) - Esophagus Cancer | Phase 1 / Phase 2 | Recruiting | West China Hospital | 45 | 2025-09-10 | 2025-12-03 |
| A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors BMS-986500, Palbociclib, Fulvestrant - Advanced Solid Tumor, Advanced Breast Cancer | Phase 1 | Recruiting | Bristol-Myers Squibb | 234 | 2025-08-01 | 2026-10-06 |
| A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations Almonertinib, Palbociclib - EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor | Phase 1 / Phase 2 | Recruiting | Sun Yat-sen University | 71 | 2025-06-09 | 2025-06-04 |
| A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet - Metastatic Breast Cancer, Breast Cancer Stage I | Phase 1 / Phase 2 | Recruiting | Forward Pharmaceuticals Co., Ltd. | 196 | 2025-06-01 | 2026-01-07 |
| A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection - Advanced Breast Cancer | Phase 1 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | 382 | 2025-04-30 | 2025-04-23 |
| SNV4818 in Participants With Advanced Solid Tumors SNV4818, Fulvestrant, Palbociclib - Advanced Solid Tumors | Phase 1 / Phase 2 | Recruiting | Pikavation Therapeutics, Inc. | 320 | 2025-02-20 | 2026-03-13 |
| A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma Mirdametinib, Palbociclib - Well Differentiated Liposarcoma, Dedifferentiated Liposarcoma | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 54 | 2025-02-19 | 2026-09-16 |
| A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer HP568, HP568 in combination with palbociclib - Breast Cancer | Phase 1 / Phase 2 | Not yet recruiting | Hinova Pharmaceuticals Inc. | 204 | 2025-01-07 | 2025-01-03 |
| Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1) Pazopanib Oral Tablet, Palbociclib - Solid Tumor, Adult, Next-generation Sequencing | Phase 1 / Phase 2 | Recruiting | Tianjin Medical University Second Hospital | 65 | 2024-11-27 | 2025-03-26 |
| Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas Camrelizumab, Palbociclib(100mg), Palbociclib(125mg) - Esophageal Squamous Cell Carcinoma | Phase 1 | Active not recruiting | West China Hospital | 6 | 2024-10-27 | 2026-04-02 |
| Palbociclib and Pembrolizumab in Sarcoma Palbociclib, Pembrolizumab - Sarcoma | Phase 1 | Recruiting | John Rieth | 8 | 2024-02-01 | 2026-05-22 |
| A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors AZD8421, Camizestrant, Ribociclib - ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC) | Phase 1 / Phase 2 | Active not recruiting | AstraZeneca | 55 | 2023-12-05 | 2026-10-28 |
| Study of AVZO-021 in Patients With Advanced Solid Tumors AVZO-021, Palbociclib, Fulvestrant - Advanced Solid Tumor, HR+/HER2- Breast Cancer | Phase 1 / Phase 2 | Recruiting | Avenzo Therapeutics, Inc. | 430 | 2023-08-30 | 2026-09-28 |
| Tazemetostat and Palbociclib With CPX-351for R/R AML Tazemetostat, Liposome-encapsulated Daunorubicin-Cytarabine, Bone Marrow Aspiration and Biopsy - Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia | Phase 1 | Recruiting | Thomas Jefferson University | 24 | 2023-08-28 | 2026-03-12 |
| First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors STX-478, Fulvestrant, Ribociclib - Breast Cancer, Solid Tumors, Adult | Phase 1 / Phase 2 | Recruiting | Eli Lilly and Company | 880 | 2023-04-17 | 2026-07-07 |
| 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 |
| Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF Targeting LncRNA SNP, Palbociclib 125mg, Bevacizumab - Cancer, Solid Tumor | Phase 1 | Recruiting | Lebanese University | 50 | 2023-02-15 | 2024-03-12 |
| A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer TOS-358, Fulvestrant, Palbociclib - HR+/HER2-negative Breast Cancer | Phase 1 | Recruiting | Totus Medicines | 241 | 2023-02-15 | 2026-04-22 |
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Breast Neoplasms (53) · Neoplasms (10) · Neoplasm Metastasis (7) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (6) · Leukemia, Myeloid, Acute (5) · Pancreatic Neoplasms (5) · Head and Neck Neoplasms (4) · Melanoma (4) · Ovarian Neoplasms (4) · Carcinoma, Non-Small-Cell Lung (3) · Colorectal Neoplasms (3) · Endometrial Neoplasms (3) · Hereditary Sensory and Autonomic Neuropathies (3) · Lung Neoplasms (3) · Lymphoma, Mantle-Cell (3)
Pfizer (17) · Dana-Farber Cancer Institute (5) · AstraZeneca (4) · Genentech, Inc. (3) · Hoffmann-La Roche (3) · M.D. Anderson Cancer Center (3) · Memorial Sloan Kettering Cancer Center (3) · Abramson Cancer Center at Penn Medicine (2) · Emory University (2) · Georgetown University (2) · Lebanese University (2) · Peter MacCallum Cancer Centre, Australia (2) · Relay Therapeutics, Inc. (2) · Royal Marsden NHS Foundation Trust (2) · Weill Medical College of Cornell University (2)
United States (91) · Spain (18) · Australia (15) · United Kingdom (14) · China (11) · South Korea (10) · France (8) · Japan (7) · Israel (6) · Italy (6) · Belgium (5) · Canada (5) · Germany (5) · Netherlands (5) · Brazil (2)
Nehman Makdissy, Professor (2) · Alicia Okines (1) · Amy Tiersten, MD (1) · Anja Wiliams (1) · Anthony Hoffman, MD (1) · Ayca Gucalp, MD (1) · Barbara Haley, MD (1) · Brent Rexer, MD, PhD (1) · Claudine Isaacs, MD (1)
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