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Tyrosine Kinase Inhibitor

Repotrectinib Drug Interactions for Advanced Cancer

Phase 1
Waitlist Available
Research Sponsored by Turning Point Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 28 days of first cocktail dose
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the safety & effectiveness of a new cancer drug on advanced cancer patients. #CancerResearch #DrugTrial

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not specified here, common side effects of cancer treatments like repotrectinib may include fatigue, nausea, diarrhea and liver function changes. Metformin can cause digestive upset; digoxin may affect heart rhythms; rosuvastatin might lead to muscle pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 28 days of first cocktail dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 28 days of first cocktail dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under plasma-concentration time curve
Maximum Observed Plasma Concentration
Secondary study objectives
Evaluate safety and tolerability

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Repotrectinib (TPX-0005)Experimental Treatment4 Interventions
Phase 1 Oral repotrectinib (TPX-0005) + cocktail drugs (metformin hydrochloride, digoxin, rosuvastatin calcium)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1990
Digoxin
2017
Completed Phase 4
~670
Rosuvastatin Calcium
2008
Completed Phase 3
~1570

Find a Location

Who is running the clinical trial?

Turning Point Therapeutics, Inc.Lead Sponsor
9 Previous Clinical Trials
865 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,582 Previous Clinical Trials
3,388,674 Total Patients Enrolled

Media Library

TPX-0005 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05828303 — Phase 1
Solid Tumors Research Study Groups: Repotrectinib (TPX-0005)
Solid Tumors Clinical Trial 2023: TPX-0005 Highlights & Side Effects. Trial Name: NCT05828303 — Phase 1
TPX-0005 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05828303 — Phase 1
~8 spots leftby Jul 2025