drugset / Trial / NCT00613223

Ph I Dose Escalation Trial of Vandetanib in Combo w Etoposide for Malignant Gliomas

NCT00613223

Phase 1 Completed 49 enrolled Annick Desjardins AstraZeneca · collab
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

EvaluationDrugModalityDoseRoute
Subject Vandetanib Small molecule 100 mg Oral
Subject Vandetanib Small molecule 200 mg Oral
Background Etoposide Small molecule 50 mg Oral

Indications