Status:
TERMINATED
Study of Crenolanib, a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Conditions:
Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the antitumor efficacy of crenolanib (CP-868,596) in patients with recurrent high grade glioma and in patients with low grade glioma.
Detailed Description
This Phase II study is designed to evaluate the antitumor efficacy of crenolanib (CP-868,596) in patients with recurrent high grade glioma and in patients with low grade glioma. Concurrently, the phar...
Eligibility Criteria
Inclusion
- Male or female, of any racial or ethnic group
- Age 18 years or older
- Patient able and willing to provide informed consent
- Adequate kidney and liver function
- Karnofsky Performance Status ≥ 70%
- Negative serum pregnancy test or child bearing potential terminated by surgery, radiation, menopause or current use of two approved methods of birth control
- Imaging suggestive of malignant glioma (Cohort A)
- History of glioma with measurable disease by MRI (Cohorts B and C)
- Histologically confirmed GBM with radiographic progression (Cohort B). These patients are permitted to have had prior therapy including surgery, radiation, Temozolomide, irinotecan and bevacizumab.
- Histological confirmation of a low-grade glioma (Cohort C)
Exclusion
- Patient unable to provide informed consent (comatose or markedly cognitively impaired)
- Female participants that are pregnant or breastfeeding
- Any other concurrent anticancer therapy
- Karnofsky Performance status \< 70%
- Any other concurrent investigational agents within 4 weeks of start of study drug
- Patients with liver disease (known or active Hepatitis B or C; steatohepatitis; cirrhosis)
- Hepatic:
- Bilirubin greater than 1x the upper limit of normal
- Transaminases greater than 1x the upper limit of normal
- Abnormal renal function
- o Serum creatinine \>1.7 ng/dl
- Patients on concomitant medications that induce or inhibit CYP450, such as enzyme inducing anti-epileptic drugs (EIAEDs) (Appendix III) and troglitazone
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01229644
Start Date
April 1 2011
End Date
December 1 2012
Last Update
July 5 2018
Active Locations (1)
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1
Harold Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390