Date: 2016-07-21
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Arog Pharmaceuticals (USA -TX)
Product: crenolanib
Action
mechanism: tyrosine kinase inhibitor. Crenolanib besylate is an investigational inhibitor being developed by AROG Pharmaceuticals. This orally bioavailable benzamidazole selectively and potently inhibits signaling of wild-type and mutant isoforms of class III receptor tyrosine kinases FLT3 (FMS-like Tyrosine Kinase 3), PDGFR ? (Platelet-Derived Growth Factor Receptor), and PDGFR ß.
Disease: advanced or metastatic gastrointestinal stromal tumors (GIST) with D842V mutated PDGFRA gene
Therapeutic area: Cancer - Oncology
Country: France, Germany, Italy, Norway, Poland, Spain, UK, USA
Trial
details: This multicenter, randomized, double-blinded, placebo-controlled, trial is evaluating 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. (NCT02847429)
Latest
news: * On July 21, 2016, a Phase 3 trial sponsored by Arog Pharmaceuticals was published on the NIH website ClinicalTrials.gov for crenolanib and is currently recruiting participants.
