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Kinase Inhibitor

Ripretinib Drug Interaction Study for Gastrointestinal Stromal Tumor

Phase 1
Recruiting
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.
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

Study 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.Check my eligibility
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.See study design
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
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I am 18 years old or older.
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My GIST has worsened or I couldn't tolerate 2 types of TKI treatments.
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I have been diagnosed with GIST.
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I can take care of myself and perform daily activities.
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My organs and bone marrow are working well.

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.
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Incidence of Adverse Events

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
~110
Repaglinide
2016
Completed Phase 4
~7040

Find a Location

Who is running the clinical trial?

Deciphera Pharmaceuticals LLCLead Sponsor
16 Previous Clinical Trials
2,214 Total Patients Enrolled

Media Library

Ripretinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04530981 — Phase 1
Gastrointestinal Stromal Tumor Research Study Groups: Repaglinide 0.5 mg + Ripretinib 150 mg QD
Gastrointestinal Stromal Tumor Clinical Trial 2023: Ripretinib Highlights & Side Effects. Trial Name: NCT04530981 — Phase 1
Ripretinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04530981 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this research endeavor?

"Affirmative. Data on clinicaltrials.gov highlights that this medical trial, whose first posting was made on September 22nd 2021, is actively enrolling patients. A total of 30 participants are needed from three separate sites."

Answered by AI

Has Ripretinib been evaluated in other clinical experiments?

"Ripretinib was first tested in 2021 at Renji Hospital, which is part of the Shanghai Jiaotong University School of Medicine. Since then 50 trials have been completed and 2 are ongoing around Portland, Oregon."

Answered by AI

What purpose is Ripretinib usually prescribed for?

"Ripretinib is a treatment that can be leveraged for exercise, gastrointestinal stromal tumor (GIST) and therapeutic measures."

Answered by AI

What is the cap on participants in this clinical examination?

"Affirmative. Clinicaltrials.gov provides evidence that this medical research is presently enrolling patients, with the first post having been made on September 22nd 2021 and its most recent update taking place November 17th 2022. Altogether, 30 individuals from 3 different centres need to be recruited for this experiment."

Answered by AI

Has Ripretinib been verified by the FDA?

"Due to the limited clinical data available, our team at Power has assigned a score of 1 when ranking Ripretinib's safety relative to other medications. As this is still Phase 1 trial, more research is needed before any definitive conclusions can be made about its efficacy and potential risk factors."

Answered by AI
~4 spots leftby Aug 2024