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NCT03465722 · ClinicalTrials.gov registry record · Phase 3
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
A Phase 3 study of GIST, sponsored by Blueprint Medicines Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 476
- Enrollment target
- 20
- Study locations
NCT03465722: Completed Phase 3 study of GIST, sponsored by Blueprint Medicines Corporation.
NCT03465722 is a Phase 3 study of GIST that has completed, run by Blueprint Medicines Corporation. The registered enrollment target is 476 participants, above the 77-participant average among 8 other GIST trials with a reported enrollment target (518% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03465722, a Phase 3 study of GIST, has completed, sponsored by Blueprint Medicines Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 476 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
Primary Outcome
To demonstrate the efficacy of avapritinib based on progression-free survival (PFS) determined by central radiological assessment per modified Response Evaluation Criteria in Solid Tumors (mRECIST), version 1.1 in patients with advanced GIST following 2 or 3 regimens of prior treatment with a tyrosine kinase inhibitor (TKI), including imatinib, compared to patients treated with regorafenib. A progressively growing tumor must meet the following criteria: a) the target lesions must be greater or e
Conditions Studied
Interventions
- DRUG regorafenib
- DRUG avapritinib
Study Locations (20)
Florida
- Mayo Clinic Cancer Center - Jacksonville
- University of Miami - Miami
- Moffitt Cancer Center - Tampa
Colorado
- University of Colorado Hospital - Aurora
- Rocky Mountain Cancer Centers - Boulder
Illinois
- Northwestern Medicine - Chicago
- The University of Chicago Medical Center - Chicago
Arizona
- Mayo Clinic Cancer Center - Phoenix
California
- UCLA Hematology/Oncology - Santa Monica - Santa Monica
District of Columbia
- Washington Hospital Center - Oncology and Hematology - Washington D.C.
Georgia
- Northside Hospital - Atlanta
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 476 participants |
| Start Date | 2018-03-26 |
| Est. Completion | 2021-09-15 |
| Phase | Phase 3 |
What the finished NCT03465722 record still lists
NCT03465722 is an interventional study that assigns participants to a tested intervention. The registered 476 participants enrollment target is mid-sized for trials with a published cap, above the 77-participant average among 8 other GIST trials with a reported enrollment target (518% higher).
The record links to 1 condition, with GIST appearing as the primary indexed condition, and to 2 interventions - of which regorafenib is the first listed.
NCT03465722 names 20 study sites across 16 states, led by Florida, Colorado, Illinois.
Frequently Asked Questions
What is clinical trial NCT03465722 about?
NCT03465722 is a clinical study titled "(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST". This is an open-label, randomized, Phase 3 study in patients with locally advanced unresectable or metastatic GIST (advanced GIST) of avapritinib (also known as BLU-285) versus regorafenib in patients previously treated with imatinib and 1 or 2 other TKIs.
What is the current status of trial NCT03465722?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 476 participants. The study started on 2018-03-26. Estimated completion is 2021-09-15.
What conditions does trial NCT03465722 study?
This clinical trial studies the following conditions: GIST.
What interventions are being tested in trial NCT03465722?
The interventions under investigation include: regorafenib (DRUG), avapritinib (DRUG).
Who is sponsoring clinical trial NCT03465722?
This trial is sponsored by Blueprint Medicines Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03465722 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for GIST
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03465722's enrollment target sits among peer trials
476 1st of 8 higher than 8 of 8 other GIST trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other GIST 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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