Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST

Status unconfirmed · Phase 3 · Has a placebo group

Conditions studied: GIST With D842V Mutated PDGFRA Gene

In brief

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.

Key facts

Study ID

NCT02847429

Run by

Arog Pharmaceuticals, Inc.

People needed

120

Starts

2016-08-01

Expected to finish

2021-08-01

Last updated by the study team

2021-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• HELIOS Klinikum Berlin-Buch — Berlin, Germany
• Mannheim University Medical Centre, University of Heidelberg — Mannheim, Germany
• Universitätsklinikum München — Munich, 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
• University Hospital The Norwegian Radium Hospital — Oslo, Norway
• M Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology — Warsaw, Poland
• Vall d'Hebron University Hospital — Barcelona, Spain
• Hospital Universitario Puerta de Hierro — Madrid, Spain
• Hospital Virgen del Rocio — Seville, Spain
• Fundación Instituto Valenciano de Oncología — Valencia, Spain

Full record on ClinicalTrials.gov

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