Status:
COMPLETED
Study of Crenolanib for the Treatment of Patients With Advanced GIST With the D842-related Mutations and Deletions in the PDGFRA Gene
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Conditions:
D842-related Mutant GIST
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 mode...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female, of any racial or ethnic group
- Age 18 years or older
- Life expectancy of greater than 12 weeks
- Patient able and willing to provide informed consent
- Normal liver function, defined as AST and ALT ≤2.5x ULN, and Total Bilirubin ≤ 2x ULN.
- Total creatinine ≤ 1.5x ULN
- ECOG Performance Status 0 - 2 (Appendix II)
- Patients must have histologically or cytologically confirmed GIST with a D842-related mutation or deletion on the PDGFRA gene
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
- Patients must have recovered from any prior therapy and completed the minimum of, either 5 half-lives of prior therapy or 2 weeks must have elapsed since prior treatment
- Exclusion Criteria
- Patient unable to provide informed consent
- ECOG Performance status \> 2
- Any concurrent anticancer therapy, immunotherapy, or hormonal therapy.
- Any other investigational agents taken within 2 weeks of start of study drug or if study drug will commence within 5 half-lives of prior therapy
- Patients with known or active Hepatitis B or C; liver cirrhosis.
- Patients with active fungal, viral, and bacterial infections
- Positive serum pregnancy test
- Pregnant or lactating women
- Patients on concomitant medications that induce or inhibit CYP3A4 (Appendix III)
- Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01243346
Start Date
April 1 2011
End Date
July 1 2014
Last Update
June 28 2018
Active Locations (2)
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1
Knight Cancer Institute, Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
2
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497