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

Stopped early · Phase 2

Conditions studied: Glioma

In brief

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.

Key facts

Study ID

NCT01229644

Run by

Arog Pharmaceuticals, Inc.

People needed

10

Starts

2011-04-01

Expected to finish

2012-12-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Harold Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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