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NCT03673501 · ClinicalTrials.gov registry record · Phase 3
A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
A Phase 3 study of Gastrointestinal Stromal Tumors, sponsored by Deciphera Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 453
- Enrollment target
- 20
- Study locations
NCT03673501: Active Phase 3 study of Gastrointestinal Stromal Tumors, sponsored by Deciphera Pharmaceuticals.
NCT03673501 is a Phase 3 study of Gastrointestinal Stromal Tumors that is active but no longer recruiting, run by Deciphera Pharmaceuticals. The registered enrollment target is 453 participants, above the 50-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (806% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03673501, a Phase 3 study of Gastrointestinal Stromal Tumors, is active but no longer recruiting, sponsored by Deciphera Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 453 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Conditions Studied
Interventions
- DRUG Sunitinib
- DRUG Ripretinib
Study Locations (20)
Florida
- Mayo Clinic Florida - Jacksonville
- Sylvester Comprehensive Cancer Center - Miami
- Miami Cancer Institute at Baptist Health, Inc. - Miami
- Orlando Health UF Health Cancer Center - Orlando
- Moffitt Cancer Center - Tampa
California
- University of California San Diego Medical Center - La Jolla
- UCLA Hematology Oncology Center - Main Site - Los Angeles
- Stanford Medicine - Stanford
Colorado
- University of Colorado Hospital - Anschutz Cancer Pavillion - Aurora
- Rocky Mountain Cancer Centers - Denver
Georgia
- Winship Cancer Institute - Atlanta
- Georgia Cancer Specialists - Sandy Springs
Illinois
- Northwestern Memorial Hospital - Chicago
- University of Chicago Medical Center - Chicago
Arizona
- Mayo Clinic Scottsdale - Scottsdale
Connecticut
- Smilow Cancer Hospital at Yale - New Haven
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 453 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
What the registry record for NCT03673501 still lists
NCT03673501 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 50-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (806% higher).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib is the first listed.
NCT03673501 names 20 study sites across 11 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT03673501 about?
NCT03673501 is a clinical study titled "A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib". 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 ripretin...
What is the current status of trial NCT03673501?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2019-02-08. Estimated completion is 2026-12.
What conditions does trial NCT03673501 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT03673501?
The interventions under investigation include: Sunitinib (DRUG), Ripretinib (DRUG).
Who is sponsoring clinical trial NCT03673501?
This trial is sponsored by Deciphera Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03673501 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03673501's enrollment target sits among peer trials
453 1st of 10 higher than 10 of 10 other Gastrointestinal Stromal Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Stromal Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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