← Back to Search

Kinase Inhibitor

Ripretinib Drug Interaction Study for Gastrointestinal Stromal Tumor

Phase 1

Waitlist Available

Research Sponsored by Deciphera Pharmaceuticals, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥18 years of age.

Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.

Must not have

History or presence of clinically relevant cardiovascular abnormalities.

Prior treatment with ripretinib.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 and cycle 1 day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). each cycle is 28 days.

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how well the drug ripretinib works when taken with a CYP2C8 substrate.

Who is the study for?

This trial is for adults with advanced GIST who've had at least two prior treatments fail or cause intolerance. They must be able to perform daily activities (ECOG ≤2), not be pregnant, agree to use contraception, and have no history of diabetes or significant heart issues. They can't join if they've taken cancer drugs or investigational therapies within the past month, used repaglinide in the last 14 days, have trouble taking oral meds, or were previously treated with ripretinib.

What is being tested?

The study is testing how Ripretinib affects the body's handling of a drug called Repaglinide which is processed by liver enzymes (CYP2C8). Participants will receive both medications under observation to see if there are any changes in how quickly their bodies process Repaglinide when also taking Ripretinib.

What are the potential side effects?

Possible side effects include those related to Ripretinib such as fatigue, nausea, hair color changes, muscle pain and skin problems. Since this trial involves studying drug interactions with Repaglinide primarily used for diabetes treatment but given here for research purposes only - specific side effects from this combination will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

My GIST has worsened or I couldn't tolerate 2 types of TKI treatments.

Select...

I have been diagnosed with GIST.

Select...

I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have significant heart problems.

Select...

I have been treated with ripretinib before.

Select...

I can take pills and do not have issues absorbing nutrients.

Select...

I have diabetes (type 1 or type 2).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 and cycle 1 day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). each cycle is 28 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 and cycle 1 day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). each cycle is 28 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 and cycle 1 day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). each cycle is 28 days. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC from time 0 and extrapolated to infinity (AUC0-∞)

Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide

Maximum Observed Plasma Concentration for Repaglinide

Secondary study objectives

Incidence of Adverse Events

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: Repaglinide 0.5 mg + Ripretinib 150 mg QDExperimental Treatment2 Interventions

A single dose of repaglinide 0.5 mg (1 × 0.5-mg tablet) will be administered orally on Cycle 1 Day 1 and Cycle 1 Day 15. Ripretinib 150 mg QD (3 × 50-mg tablets) will be administered orally from Day 2 through Day 28 for Cycle 1 and will be administered continuously from Cycle 2 until disease progression as assessed by the Investigator, unacceptable toxicity, or withdrawal of consent.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ripretinib

2020

Completed Phase 2

~130

Repaglinide

2016

Completed Phase 4

~7010