drugset / Trial / NCT02847429
Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST
Phase 3
Unknown
120 enrolled
Arog Pharmaceuticals, Inc.
Centre Leon Berard · collabFox Chase Cancer Center · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2016-08
- Primary completion
- 2021-08
- Completion
- 2021-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Crenolanib | Small molecule | 100 mg | Oral |