Repotrectinib Drug Interactions for Advanced Cancer

Recruiting at 39 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Turning Point Therapeutics, Inc.

Must not be taking: CYP3A inhibitors, Metformin, others

Disqualifiers: Cardiovascular disease, Active infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with advanced solid tumors, including CNS tumors, that have specific gene fusions (ROS1 or NTRK1-3). Participants must be in fairly good health based on ECOG status and lab tests. They can't join if they have symptomatic brain metastases, significant heart disease, are in another clinical trial, had major surgery recently, have active infections needing treatment, use certain other drugs or have gastrointestinal issues affecting drug absorption.

Inclusion Criteria

Protocol specified baseline hematology, liver function and kidney function laboratory values

I am 18 or older and can do most of my daily activities.

My cancer has a ROS1 or NTRK gene fusion.

Exclusion Criteria

I am taking or will take drugs that strongly affect liver enzyme activity.

I have a condition that affects how my body absorbs nutrients.

I haven't taken drugs that affect certain body transport systems within the last 14 days or 5 half-lives.

Treatment Details

Interventions

• TPX-0005

Trial Overview The study is testing how repotrectinib (TPX-0005) affects the body's handling of metformin hydrochloride, digoxin and rosuvastatin calcium. It aims to understand potential interactions between repotrectinib and these medications when taken by patients with advanced cancer.

Participant Groups

Group I: Repotrectinib (TPX-0005) Experimental Treatment 4 Interventions

Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)

Who Is Running the Clinical Trial?

Turning Point Therapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

790+