TRIAL DETAIL

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

Drug:
Trial Name:
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
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Completed
Phase:
2
Start Date 04/13/2011
Age of Trial (yrs) 13
Treatment Phase:
First-line and Gleevec-Resistant
Drug Category:
D842V
Strategy:
Block PDGFRA
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
ARO-BRE-002
Sponsor:
Arog Pharmaceuticals LLC
Patient Contact:
Abhijit Ramachandran, M.S. 214-593-0515 aramachandran@arogpharma.com Morgan Grant 214-593-0588 mgrant@arogpharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

 

Trial Results

Drug Information

AROG website - produce pipeline
 
Phase 1 study of CP-868,596 an oral, highly specific PDGFR inhibitor.
 
Phase Ib study of CP-868,596, a PDGFR inhibitor, combined with docetaxel with or without axitinib, a VEGFR inhibitor
 
NCI Drug Thesaurus
 
2011 AACR abstract - CP-868,596, a highly potent PDGFR inhibitor, inhibits phosphorylation of the imatinib-resistant PDGFRA D842V activating mutation associated with advanced GIST
 
D842V gets its moment in the spotlight
 
Phase I poster from 2011 AACR (PDF)
 
CTOS 2011 Poster - EFFICACY OF CRENOLANIB AGAINST THE PDGFRA ACTIVATING MUTATION, D842V, ASSOCIATED WITH GASTROINTESTINAL STROMAL TUMORS (PDF - 529 KB)
 
PRELIMINARY REPORT OF CRENOLANIB IN THE TREATMENT OF ADVANCED PLATELET DERIVED GROWTH FACTOR A (PDGFRA) D842V MUTANT GASTROINTESTINAL STROMAL TUMOR (GIST) (PDF 613 KB)
 
Crenolanib Inhibits the Drug-Resistant PDGFRA D842V Mutation Associated with Imatinib-resistant Gastrointestinal Stromal Tumors
 
FDA grants fast track designation for crenolanib fof advanced GIST with a D842V mutation in PDGFRA
 

Trial Sites

Name
Address
City
State
Zip
Country
333 Cottman Ave
Philadelphia
PA
19111
USA
3181 S.W. Sam Jackson Park Rd.
Portland
OR
97239
USA