(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST

Gastrointestinal Stromal Tumor

Active, not recruiting

3

Start Date 03/26/2018

Age of Trial (yrs) 6.7

Gleevec-resistant

KIT/PDGFRA inhibitor + D842V inhibitor

Block KIT/PDGFRA

Specifically GIST and only GIST

BLU-285-1303

Blueprint Medicines Corporation

Blueprint Medicines 617-714-6707 studydirector@blueprintmedicines.com

Randomized

Oral

Brief 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.

nclusion Criteria:

Patients who are ≥ 18 years of age.
Patients who have histologically confirmed metastatic or unresectable GIST.
Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.

Exclusion Criteria (Partial):

Patients who have received prior treatment with avapritinib or regorafenib.
Patients who have received more than 3 different prior TKI treatment regimens.
Patients who are known to be both V-kit Hardy-Zuckerman 4 feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRFα) wild type.