drugset / Trial / NCT00807170

Investigate the Maximum Tolerated Dose of Vandetanib and Concurrent Whole Brain Radiotherapy (WBRT) in Patients With Non-small Cell Lung Cancer (NSCLC) and Brain Metastases

NCT00807170

Phase 1 Terminated 5 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

A clinical study to investigate the maximum tolerated dose of Vandetanib and concurrent WBRT in patients with NSCLC and brain metastases. All patients will receive WBRT, 10 fractions of 3 Gy. Patients will start 7 days prior to start of radiation treatment with Vandetanib. Total treatment time with Vandetanib is 3 weeks (21 days). Patients will have the opportunity to continue Vandetanib until progression at a dose of 300 mg. This multi-centre study will be conducted in a minimum of 9 patients and a maximum of 18 patients at 3 sites.

Timeline

Start
2009-05
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Vandetanib Small molecule 100 mg Oral
Subject Vandetanib Small molecule 200 mg Oral
Subject Vandetanib Small molecule 300 mg Oral