drugset / Trial / NCT00734864
Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ). Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity with this regimen in this patient population.
Timeline
- Start
- 2009-06
- Primary completion
- 2010-06
- Completion
- 2012-06
Outcome
Outcome not reported
Stopped: “Study drug supplier withdrew support for the study. Study was withdrawn from the Duke IRB.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Carbamazepine | Small molecule | — | — |
| Background | Fosphenytoin | Small molecule | — | — |
| Background | Oxcarbazepine | Small molecule | — | — |
| Background | Phenobarbital | Unknown | — | — |
| Background | Phenytoin | Unknown | — | — |
| Background | Primidone | Small molecule | — | — |