Ripretinib vs Sunitinib for Gastrointestinal Stromal Tumors
(INTRIGUE Trial)

Recruiting in Palo Alto (17 mi)

+119 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Deciphera Pharmaceuticals, LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a 2-arm, randomized, open-label, international, multicenter study comparing the efficacy of ripretinib to sunitinib in GIST patients who progressed on or were intolerant to first-line anticancer treatment with imatinib. Approximately 426 patients will be randomized in a 1:1 ratio to ripretinib 150 mg once daily (continuous dosing for 6 week cycles) or sunitinib 50 mg once daily (6 week cycles, 4 weeks on, 2 weeks off).

Eligibility Criteria

This trial is for adults over 18 with Gastrointestinal Stromal Tumors (GIST) who've had issues with the first-line treatment, imatinib. They need a confirmed diagnosis and must provide tissue samples for testing. Participants should be relatively fit (ECOG PS ≤2), not pregnant, willing to use contraception, have at least one measurable tumor lesion, and stable organ function.

Inclusion Criteria

If you can have children, you must agree to use birth control as detailed in the study rules.

I have a tumor that can be measured by scans.

I am 18 years old or older.

+7 more

Participant Groups

The study compares two drugs: Ripretinib taken daily in continuous 6-week cycles versus Sunitinib taken daily for 4 weeks on/2 weeks off in similar cycles. It's designed to see which drug works better after imatinib fails in advanced GIST patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: RipretinibExperimental Treatment1 Intervention

Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles

Group II: SunitinibActive Control1 Intervention

Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.