Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of Crenolanib in Subjects With Advanced or Metastatic Gastrointestinal Stromal Tumors With a D842V Mutation in the PDGFRA Gene

NCT02847429•Arog Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blinded, placebo-controlled, trial of oral crenolanib versus oral placebo in combination with best supportive care in subjects with advanced or metastatic GIST with a D842V mutation in the PDGFRA gene. Approximately 120 subjects will be randomized in a 2:1 ratio to receive either crenolanib 100 mg or matching placebo orally (PO) 3 times daily (TID) in combination with best supportive care.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
•2. Measurable disease as per modified RECIST 1.1
•• A lesion in an area that was previously treated with local therapy (e.g. radiation, surgery, or cryotherapy) can be considered measurable disease as long as there is objective evidence of progression of the lesion prior to randomization
•3. Subjects (male or female) ≥ 18 years of age
•4. Female subjects with reproductive potential must have negative serum or urine pregnancy test
•5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria

•1. Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
•2. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
•3. Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
•4. Systemic anti-cancer treatment (e.g. chemotherapy, tyrosine kinase inhibitors, immunotherapy, or investigational agents) or investigational device within 3 weeks or 5 half-lives (if the drug's half-life in subject is known) prior to randomization, whichever is shorter

Locations (23)

Sarcoma Oncology Center

Santa Monica, California, United States

University of Miami

Miami, Florida, United States

Duke Cancer Institute

Durham, North Carolina, United States

Oregon Health and Science University

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Institut Bergonie

Bordeaux, France

Centre Leon Berard

Lyon, France

La Timone University Hospital

Marseille, France

Centre Hospitalier Universitaire (CHU) de Reims

Reims, France

Key Dates

Start Date

August 1, 2016

Primary Completion Date

August 1, 2021

Completion Date

August 1, 2021

Last Updated

January 22, 2021

Enrollment

120

ESTIMATED participants

Conditions

GIST With D842V Mutated PDGFRA Gene

Interventions

Crenolanib

DRUG

Placebo

DRUG