NCT05828303

A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors

A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors Harboring ROS1 or NTRK1-3 Rearrangements

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Turning Point Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 1, open-label, fixed-sequence study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on drug transporters (metformin, digoxin and rosuvastatin) following multiple dose administration of repotrectinib in patients with advanced cancer harboring ROS1 and NTRK1 Rearrangements.

Conditions

• Advanced Solid Tumor
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	TPX-0005	Oral TPX-0005 capsules
DRUG	Metformin Hydrochloride	oral solution
DRUG	Digoxin	oral tablet
DRUG	Rosuvastatin Calcium	oral tablet

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-07-31
• Completion: 2025-11-30
• First posted: 2023-04-25
• Last updated: 2025-04-01

Locations

33 sites across 6 countries: United States, Australia, Brazil, France, Italy, Spain

Regulatory

• FDA-regulated drug study