A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
Part of paid clinical trials in Canton, Ohio.
- Sponsor
- Turning Point Therapeutics, Inc.
- Study ID
- NCT05828303
- Phase
- PHASE1
- Status
- Withdrawn
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TPX-0005 — DRUGOral TPX-0005 capsules
- Metformin Hydrochloride — DRUGoral solution
- Digoxin — DRUGoral tablet
- Rosuvastatin Calcium — DRUGoral tablet
Study Details
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
Key Dates
- Start date
- Nov 15, 2024
- Status verified
- Mar 2025
- Primary completion
- Jul 31, 2025
- Completion
- Nov 30, 2025
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Repotrectinib (TPX-0005)Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
Primary Outcome Measure
Area under plasma-concentration time curve [ Time Frame: Within 28 days of first cocktail dose ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Gabrail Cancer Research Center | Canton | Ohio | 44718 | - |
| Local Institution - 2101 | Canton | Ohio | 44718 | - |
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