IRB #

STUDY00018437

Title

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)

Principal Investigator

Michael Heinrich

Study Purpose

To determine the safety and efficacy of avapritinib (BLU-285) in patients with previously treated advanced GIST.

Medical Condition(s)

GIST with D842 mutation in PDGFRa and GIST with other mutations

Eligibility Criteria

1. 18 years or older

2. Patients with GIST that cannot be removed surgically and has progressed following treatment with imatinib and 1 or 2 other tyrosine-kinase inhibitor (TKI) therapies.

3. Patient cannot be both KIT and PDGRFα wild type.


Other eligibility criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

- Participants will receive the study drug until their disease gets worse or they develop intolerable side effects.
- The study doctor will follow a participants condition every 2 months until the study is closed by the Sponsor or the participant withdraws consent.
- If a participant comes off study treatment for reasons other than disease progression they will continue to receive scans every 8 weeks until progression.
- After confirmed progression the study doctor will call the participant approximately every 2 months to ask about any new therapy they are receiving.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Blueprint Medicines Corporation

Recruitment End

12/31/2020

Compensation Provided

No


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