Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

A Phase 1b/2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

NCT05080621•Deciphera Pharmaceuticals, LLC

View on ClinicalTrials.gov

Summary

Multicenter, open-label Phase 1b/2 study of ripretinib in combination with binimetinib in patients with gastrointestinal stromal tumor (GIST). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients ≥18 years of age with advanced GIST (unresectable or metastatic).
•2. Must have at least progressed on imatinib or have documented intolerance to imatinib.
•3. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
•4. Patients must have a histologic diagnosis of GIST.
•5. If a female of childbearing potential, must have a negative pregnancy test.
•6. Adequate organ function and bone marrow function

Exclusion Criteria

•1. Received prior anticancer therapy within 14 days or 5× the half-life whichever is longer) prior to the first dose.
•2. Ongoing or prior participation in the DCC-2618-03-002 study.
•3. Prior therapy with ripretinib.
•4. Prior therapy with MEK inhibitor.
•5. History of certain ocular disorders.
•6. History of clinically significant hepatobiliary disease.
•7. Known active central nervous system metastases.
•8. History or presence of clinically relevant cardiovascular abnormalities.
•9. Systemic arterial or venous thrombotic or embolic events within 6 months of first dose.
•10. History of acute or chronic pancreatitis
+4 more criteria

Key Dates

Start Date

November 1, 2021

Primary Completion Date

November 1, 2025

Completion Date

May 1, 2027

Last Updated

January 5, 2022

Conditions

Gastrointestinal Stromal Tumors

Interventions

Ripretinib

DRUG

binimetinib

DRUG

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ripretinib in Combination With Binimetinib in Patients With Gastrointestinal Stromal Tumor (GIST)

Inclusion Criteria

Exclusion Criteria

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence

Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST