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
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|ClinicalTrials.gov Identifier: NCT01243346|
Recruitment Status : Completed
First Posted : November 18, 2010
Last Update Posted : November 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|D842-related Mutant GIST||Drug: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2014|
|Experimental: Crenolanib (CP-868,596)||
Drug: Crenolanib besylate (CP-868,596-26), Dose: 140mg BID
Highly potent inhibitor of both PDGFR receptors alpha and beta
- The primary end-point is overall response rate [ Time Frame: 1.5 years ]To determine the response rate of patients with advanced D842V mutant GIST, when treated with Crenolanib (CP-868,596). Response will primarily be determined by RECIST criteria
- Progression free survival rate [ Time Frame: 6 months ]To determine the progression free survival rate at 6 months in patients with advanced GIST with the D842V mutation in the PDGFRA gene, when treated with CP-868,596 (crenolanib).
- Obtain toxicity information [ Time Frame: 1 year ]To obtain additional toxicity information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.
- PKPD analysis [ Time Frame: 1 year ]To obtain additional PK, pharmacodynamic and plasma inhibitory assay information in patients with advanced GIST with the D842V mutation in the PDGFRA gene.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01243346
|United States, Oregon|
|Knight Cancer Institute, Oregon Health and Science University|
|Portland, Oregon, United States, 97239-3098|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||Margaret von Mehren, MD||Fox Chase Cancer Center|
|Principal Investigator:||Michael C Heinrich, MD||OHSU Knight Cancer Institute|