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

Status: Active

Description

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.

Eligibility Criteria

Inclusion 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 1.

Exclusion Criteria

  • Patients who have received prior treatment with avapritinib or regorafenib.
  • Patients who have previously received more than 3 different 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.
  • Patients who received any systemic anticancer therapy within 1 week before the first dose of study drug.
  • Patients who have clinically significant cardiovascular disease
  • Patients have experienced arterial thrombotic or embolic events within 6 months before the first dose of study drug, or venous thrombotic events within 14 days of the first dose of study drug
  • Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before the first dose of study drug
  • Patients who have a known risk of intracranial bleeding, or a history of intracranial bleeding within 1 year prior to the first dose of study drug
  • Patients who have a symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.
  • Patients who have poor organ function as defined by laboratory parameters specified in the protocol.
  • Patients who have received neutrophil growth factor support within 14 days of first dose of study drug.
  • Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
  • Patients who have had a major surgical procedure within 14 days of the first dose of study drug. Patient has significant traumatic injury within 28 days before the first dose of study drug.
  • Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 3 years before first dose of study drug.
  • Patients who have a history of a seizure disorder requiring anti-seizure medication.
  • Patients who have metastases to the brain.
  • Patients who have a QT interval corrected using Fridericia's formula (QTcF) of > 450 msec.
  • Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 60 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of the first dose of study drug and for at least 90 days after the last dose of study drug.
  • Women who are pregnant.
  • Women who are breastfeeding.
  • Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality as determined by the investigator.

Locations & Contacts

Arizona

Scottsdale
Mayo Clinic in Arizona
Status: Active
Name Not Available

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Kim Kelly
Phone: 310-206-8309
Email: kmkelly@mednet.ucla.edu

Colorado

Aurora
University of Colorado Hospital
Status: Active
Name Not Available

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: William D. Tap
Phone: 646-888-4163
Email: tapw@mskcc.org

Oregon

Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Blueprint Medicines Corporation

Trial IDs

Primary ID BLU-285-1303
Secondary IDs NCI-2018-01086
Clinicaltrials.gov ID NCT03465722