Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
- Registration Number
- NCT02847429
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
-
Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
-
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
-
Subjects (male or female) ≥ 18 years of age
-
Female subjects with reproductive potential must have negative serum or urine pregnancy test
-
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis)
- Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Female subject who is pregnant or breastfeeding, or planning to become pregnant within 30 days after ending treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Arm Placebo Matching placebo Crenolanib Arm Crenolanib Investigational product (crenolanib)
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) will be measured from the date of randomization to the date of the first objective radiological disease progression according to centralized committee assessment using modified RECIST version 1.1 or death. 3 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) will be measured from the date of randomization to the date of death from any cause. OS will be estimated using the Kaplan-Meier method. 3 years
Trial Locations
- Locations (23)
Sarcoma Oncology Center
🇺🇸Santa Monica, California, United States
Duke Cancer Institute
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Institut Bergonie
🇫🇷Bordeaux, France
La Timone University Hospital
🇫🇷Marseille, France
Centre Hospitalier Universitaire (CHU) de Reims
🇫🇷Reims, France
Centre Leon Berard
🇫🇷Lyon, France
HELIOS Klinikum Berlin-Buch
🇩🇪Berlin, Germany
Universitätsklinikum München
🇩🇪Munich, Germany
Mannheim University Medical Centre, University of Heidelberg
🇩🇪Mannheim, Germany
Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Istituto Nazionale Tumori
🇮🇹Milan, Italy
Institut Regina Elena / IFO
🇮🇹Rome, Italy
Candiolo Cancer Institute - FPO, IRCCS
🇮🇹Turin, Italy
Vall d'Hebron University Hospital
🇪🇸Barcelona, Spain
University Hospital The Norwegian Radium Hospital
🇳🇴Oslo, Norway
M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology
🇵🇱Warsaw, Poland
Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
University of Miami
🇺🇸Miami, Florida, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States