NCT02847429

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Arog Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• GIST With D842V Mutated PDGFRA Gene

Interventions

Type	Name	Description
DRUG	Crenolanib
DRUG	Placebo

Timeline

• Start date: 2016-08-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2016-07-28
• Last updated: 2021-01-22

Locations

23 sites across 7 countries: United States, France, Germany, Italy, Norway, Poland, Spain