Clinical trial · Interventional
Study of Crenolanib, a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas
A Phase II Study of Crenolanib (CP-868,596), a Selective and Potent Inhibitor of PDGFR, for the Treatment of Adult Gliomas
NCT01229644CI-TRIAL-00033631terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crenolanib (CP-868,596) | Drug | Crenolanib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort A
- description
- Adult newly diagnosed glioma (both low and high grade) patients, who are able to to take Crenolanib (CP-868,596) for at least 3 days prior to surgical resection.
- interventionNames
- Drug: Crenolanib (CP-868,596)
- type
- EXPERIMENTAL
- label
- Cohort B
- description
- Adult patients with recurrent high grade glioma, including patients treated with bevacizumab. Patients are treated with Crenolanib (CP-868,596) continuously until they fulfill one of the criteria for study discontinuation.
- interventionNames
- Drug: Crenolanib (CP-868,596)
- type
- EXPERIMENTAL
- label
- Cohort C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDElizabeth A. Maher1, Clinton Stewart2, Kimmo Hatanpaa1, Jack Raisanen1, Tomoyuki Mashimo1, Xiao-Li Yang1, Chaitanya Muralidhara3, Christopher Madden1, Abhijit Ramachandran3, Bruce Mickey1, Robert Bachoo1, 1University of Texas Southwestern Medical Center, Dallas, TX, 2St. Jude's Children's Research Hospital, Memphis, TN, 3AROG Pharmaceuticals, LLC, Dallas, TX Neoadjuvant administration of the potent PDGFR inhibitor, crenolanib, to malignant gliomas at initial diagnosis: does it hit the target?