Trials / Completed
CompletedNCT03465722
(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST
An International, Multicenter, Open-label, Randomized, Phase 3 Study of BLU-285 vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic Gastrointestinal Stromal Tumor (GIST)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 476 (actual)
- Sponsor
- Blueprint Medicines Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | avapritinib | Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously. |
| DRUG | regorafenib | Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off). |
Timeline
- Start date
- 2018-03-26
- Primary completion
- 2020-03-09
- Completion
- 2021-09-15
- First posted
- 2018-03-14
- Last updated
- 2022-10-06
- Results posted
- 2021-05-14
Locations
114 sites across 18 countries: United States, Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Singapore, South Korea, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03465722. Inclusion in this directory is not an endorsement.