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| Sponsor: | Arog Pharmaceuticals LLC |
|---|---|
| Information provided by: | Arog Pharmaceuticals LLC |
| ClinicalTrials.gov Identifier: | NCT01243346 |
Purpose
This Phase II study is designed to evaluate the antitumor efficacy and pharmacokinetics of crenolanib (CP-868,596) in patients with D842-related mutant metastatic GIST.
| Condition | Intervention | Phase |
|---|---|---|
|
D842-related Mutant GIST |
Drug: Crenolanib besylate (CP-868,596-26) 340mg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Crenolanib (CP-868,596), a Selective and Potent Inhibitor of PDGFR, for the Treatment of Patients With Advanced Gastrointestinal Stromal Tumors With the D842-related Mutations and Deletions, Including the D842V Mutation, in the PDGFRA Gene |
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Crenolanib (CP-868,596) |
Drug: Crenolanib besylate (CP-868,596-26) 340mg
Highly potent inhibitor of both PDGFR receptors alpha and beta
|
Crenolanib (CP-868,596) is an orally bioavailable, selective inhibitor of PDGFR receptor tyrosine kinase with IC50s of 0.4 ng/mL and 0.8 ng/mL for PDGFRα and PDGFRβ, respectively.
In preclinical models of cell lines with the D842V mutation in the PDGFRA gene, crenolanib (CP-868,596) blocked phosphorylation of PDGFRα at nanomolar concentrations, suggesting that it may provide a clinical benefit to patients with D842V mutant GIST.
In addition, crenolanib was also active in inhibiting phosphorylation of cell lines with two point mutations (double mutants) PDGFRA V561D + D842V and PDGFRA T674I + D842V.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: Haley Marshall | 214-593-0508 | hmarshall@arogpharma.com |
| Contact: Abhijit Ramachandran, M.S. | 214-593-0515 | aramachandran@arogpharma.com |
| United States, Oregon | |
| Knight Cancer Institute, Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Tracy Walker, RN, BSN walkertr@ohsu.edu | |
| Contact: Hotline 503-494-1080 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Contact: Kathleen Lear, RN, OCN, CCRP 215-214-1511 Kathleen.Lear@fccc.edu | |
| Principal Investigator: | Margaret von Mehren, MD | Fox Chase Cancer Center |
| Principal Investigator: | Michael C Heinrich, MD | OHSU Knight Cancer Institute |
More Information
| Responsible Party: | Hemanshu Shah / Chief Operating Officer, AROG Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01243346 History of Changes |
| Other Study ID Numbers: | ARO-BRE-002 |
| Study First Received: | November 17, 2010 |
| Last Updated: | January 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Gastrointestinal Stromal Tumor PDGFR Inhibitor Crenolanib (CP-868,596) |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |