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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 28 days of first cocktail dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 28 days of first cocktail dose
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
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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
1,569 Previous Clinical Trials
3,384,352 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have a serious heart condition.I have taken or will take metformin, digoxin, or rosuvastatin within 14 days before starting the drug interaction study.My heart's electrical cycle is longer than normal without medication causes.I am 18 or older and can do most of my daily activities.My cancer has a ROS1 or NTRK gene fusion.I have not had major surgery in the last 4 weeks.I have brain metastases or leptomeningeal involvement that causes symptoms.I do not have any ongoing infections needing treatment.My advanced cancer has a ROS1 or NTRK gene fusion.
Research Study Groups:
This trial has the following groups:- Group 1: Repotrectinib (TPX-0005)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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