A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
NCT05828303 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2025-04-01
Summary
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.
Conditions
- Advanced Solid Tumor
- Metastatic Solid Tumor
Interventions
- DRUG
-
TPX-0005
Oral TPX-0005 capsules
- DRUG
-
Metformin Hydrochloride
oral solution
- DRUG
-
Digoxin
oral tablet
- DRUG
-
Rosuvastatin Calcium
oral tablet
Sponsors & Collaborators
-
Turning Point Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-15
- Primary Completion
- 2025-07-31
- Completion
- 2025-11-30
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- France
- Italy
- Spain
Study Locations
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