6 recruiting, 3 completed, 2 terminated, 2 withdrawn. 10 Phase 1, 7 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 10 | Completed 3, Recruiting 3, Withdrawn 2, Terminated 1, Unknown 1 |
| Phase 2 | 7 | Recruiting 5, Terminated 2 |
| Phase 3 | 1 | Active not recruiting 1 |
Follow repotrectinib: new trials by email Literature Review of repotrectinib trials Research Report on repotrectinib
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 |
|---|---|---|---|---|---|---|
| Repotrectinib Post-Marketing Surveillance in Korean Patients With ROS1-Positive Non-Small Cell Lung Cancer (NSCLC) or Solid Tumors Harboring a Neurotrophic Tyrosine Receptor Kinase (NTRK) Gene Fusion Repotrectinib - Non-Small Cell Lung Cancer | Not yet recruiting | Bristol-Myers Squibb | 10 | 2026-10-31 | 2026-09-30 | |
| Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants Repotrectinib, Metformin, Digoxin - Healthy Volunteers | Phase 1 | Completed | Bristol-Myers Squibb | 30 | 2025-12-31 | 2026-03-27 |
| Repotrectinib Post-Marketing Surveillance in Pediatric Patients With NTRK Fusion-Positive Tumors in Japan Repotrectinib - NTRK Fusion-positive Solid Tumors | Recruiting | Bristol-Myers Squibb | 20 | 2025-11-20 | 2026-08-10 | |
| Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis Repotrectinib - NSCLC, Brain Metastases | Phase 2 | Recruiting | MedSIR | 20 | 2025-06-27 | 2026-09-09 |
| A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors TPX-0005, Metformin Hydrochloride, Digoxin - Advanced Solid Tumor, Metastatic Solid Tumor | Phase 1 | Withdrawn | Turning Point Therapeutics, Inc. | 2024-11-15 | 2025-04-01 | |
| Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC Repotrectinib - NSCLC Stage IV, NSCLC, Stage III | Phase 2 | Recruiting | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | 30 | 2024-10-01 | 2026-07-07 |
| A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants Repotrectinib, Voriconazole, Quinidine - Healthy Volunteers | Phase 1 | Completed | Bristol-Myers Squibb | 32 | 2024-08-26 | 2025-08-22 |
| Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) Fulvestrant, Repotrectinib - Hormone Receptor-positive Human Epidermal Growth Factor 2-negative, Metastatic Invasive LObular Carcinoma | Phase 2 | Terminated | M.D. Anderson Cancer Center | 6 | 2024-08-08 | 2026-01-05 |
| A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment Repotrectinib - Hepatic Impairment, Healthy Volunteers | Phase 1 | Completed | Bristol-Myers Squibb | 18 | 2024-04-29 | 2025-10-06 |
| A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) Repotrectinib, Crizotinib - Carcinoma, Non-Small-Cell Lung | Phase 3 | Active not recruiting | Bristol-Myers Squibb | 190 | 2023-12-21 | 2026-09-22 |
| A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients repotrectinib (TPX-0005) - Locally Advanced Solid Tumor, Metastatic Solid Tumor | Phase 1 | Withdrawn | Turning Point Therapeutics, Inc. | 2022-07-28 | 2023-09-26 | |
| Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients Repotrectinib, Osimertinib - Nsclc | Phase 1 | Unknown | Instituto Oncológico Dr Rosell | 32 | 2022-02-11 | 2024-04-03 |
| A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors TPX-0005, Trametinib - KRAS Mutation-Related Tumors, Metastatic Solid Tumor | Phase 1 / Phase 2 | Terminated | Turning Point Therapeutics, Inc. | 9 | 2021-09-23 | 2024-04-02 |
| A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer Repotrectinib, Irinotecan and temozolomide - Advanced Cancer, Metastatic Solid Tumor | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 77 | 2021-08-09 | 2026-06-04 |
| A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations Oral repotrectinib (TPX-0005) - Locally Advanced Solid Tumors, Metastatic Solid Tumors | Phase 1 / Phase 2 | Recruiting | Turning Point Therapeutics, Inc. | 75 | 2020-03-12 | 2026-09-25 |
| A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements Oral repotrectinib (TPX-0005) - Locally Advanced Solid Tumors, Metastatic Solid Tumors | Phase 1 / Phase 2 | Recruiting | Turning Point Therapeutics, Inc. | 500 | 2017-03-07 | 2026-05-27 |
| Expanded Access for Repotrectinib Repotrectinib | Available | Bristol-Myers Squibb | 2023-07-03 |
Carcinoma, Non-Small-Cell Lung (6) · Neoplasm Metastasis (5) · Neoplasms (2) · Sarcoma (2) · Adenocarcinoma (1) · Brain Neoplasms (1) · Bronchial Neoplasms (1) · Carcinoma (1) · Carcinoma, Bronchogenic (1) · Carcinoma, Lobular (1) · Carcinoma, Neuroendocrine (1) · Colonic Diseases (1) · Colonic Neoplasms (1) · Digestive System Neoplasms (1) · Endocrine Gland Neoplasms (1)
Bristol-Myers Squibb (7) · Turning Point Therapeutics, Inc. (5) · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (1) · Instituto Oncológico Dr Rosell (1) · M.D. Anderson Cancer Center (1) · MedSIR (1) · Memorial Sloan Kettering Cancer Center (1)
United States (11) · Spain (7) · France (5) · Italy (4) · South Korea (4) · Australia (3) · Canada (3) · Germany (3) · Japan (3) · Austria (2) · Brazil (2) · China (2) · Denmark (2) · Hungary (2) · Netherlands (2)
Emily Slotkin, MD (1) · Jason Mouabbi, MD (1)
PMID 30093503, PMID 32269053, PMID 34814185, PMID 38197815, PMID 40341199, PMID 41639379
2023 (3)