drugset / Trial / NCT00613223
Ph I Dose Escalation Trial of Vandetanib in Combo w Etoposide for Malignant Gliomas
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To determine maximum tolerated dose \& dose limiting toxicity of vandetanib when combined with standard dosing of etoposide among patients with recurrent malignant glioma who are on \& not on enzyme-inducing anti-epileptic drugs (EIAEDs) Secondary Objectives: To assess safety \& tolerability of vandetanib + etoposide in this population; To evaluate pharmacokinetics of vandetanib among malignant glioma patients on \& not on EIAEDs when combined with etoposide. Exploratory Objective: To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma patients including radiographic response rate, 6-month progression free survival (PFS) rate \& median PFS.
Timeline
- Start
- 2008-02
- Primary completion
- 2010-10
- Completion
- 2011-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vandetanib | Small molecule | 100 mg | Oral |
| Subject | Vandetanib | Small molecule | 200 mg | Oral |
| Background | Etoposide | Small molecule | 50 mg | Oral |