Phase II Study of Crenolanib (CP-868,596), for the Treatment of Patients With Advanced Gastrointestinal Stromal Tumors With the D842-related Mutations and Deletions in the PDGFRA Gene

Phase II Study of Crenolanib (CP-868,596), for the Treatment of Patients With Advanced Gastrointestinal Stromal Tumors With the D842-related Mutations and Deletions in the PDGFRA Gene

Gastrointestinal Stromal Tumor

Completed

2

Start Date 04/13/2011

Age of Trial (yrs) 13.6

First-line and Gleevec-Resistant

D842V

Block PDGFRA

Specifically GIST and only GIST

ARO-BRE-002

Arog Pharmaceuticals LLC

Abhijit Ramachandran, M.S. 214-593-0515 aramachandran@arogpharma.com Morgan Grant 214-593-0588 mgrant@arogpharma.com

Oral

PDGFRA D842V mutations are resistant to both Gleevec and Sutent (standard therapies). CP-868,596 is a new oral PDGFRA inhibitor. In lab experiments, CP-868,596 potently inhibits the D842V mutation. CP-868,596 has completed phase I trials. This is the first trial in GIST specifically for a PDGFRA inhibitor.
This trial is open to patients with metastatic GIST with a PDGFRA D842V mutation (exon 18). Patients do not have to have failed Gleevec or Sutent prior to the trial, but they are still eligible for the trial regardless of previous treatment as long at it's been one month since that treatment.
Update: Due to PK modeling suggesting sub-therapeutic doses at the original starting dose (200 mg once per day), the dose and schedule have been modified. Patients are now started at 140 mg twice per day.