IRB #

IRB00012061

Title

A Phase 1 Study of BLU-285 in Patients with Gastrointestinal Stromal Tumors (GIST) and other Relapsed and Refractory Solid Tumors

Principal Investigator

Michael Heinrich

Study Purpose

To determine the safety and efficacy of BLU-285 in patients with advanced GIST and other advanced solid tumors.

Medical Condition(s)

Part 1: GIST and other advanced solid tumors
Part 2: GIST with D842 mutation in PDGFRa and GIST with other mutations.

Eligibility Criteria

1. Male or female aged 18 or older

2a. Part 1: Patients with advanced solid tumors without available effective therapy. Patients with GIST that cannot be removed surgically and has progressed following treatment with imatinib and at least 1 other therapy. Patients with D842 mutations do not have any prior therapy requirements.

2b. Part 2: Patients with GIST that cannot be removed surgically and has progressed following treatment with imatinib and at least 1 other therapy. Patients with D842 mutations do not have any prior therapy requirements.

3. Patient cannot have a history of a seizure disorder (e.g., epilepsy) or requirement for anti-seizure medication.

Other eligibility criteria apply.

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Patients will receive the study drug until their disease gets worse or they develop intolerable side effects. If their disease was stable, they will be evaluated every 3 months until a new treatment is started or their disease worsens.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Blueprint Medicines Corporation

Recruitment End

12/31/2030

Compensation Provided

No


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