Overview

Study of Crenolanib, a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas

Status:
Terminated
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arog Pharmaceuticals, Inc.
Treatments:
Crenolanib
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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