drugset / Trial / NCT00777179

Phase II of Zactima Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

NCT00777179

Phase 2 Completed 117 enrolled Genzyme, a Sanofi Company
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is multicenter, randomized, double-blinded, placebo-controlled Phase II study comparing vandetanib (300mg daily) plus best supportive care (BSC) to placebo plus BSC as maintenance treatment in patients with locally advanced or metastatic NSCLC, who have received and responded to prior platinum-doublet systemic chemotherapy. The primary objective of the study is to compare the Progression Free Survival (PFS) rate at 3 months in locally advanced or metastatic NSCLC patients with or without vandetanib maintenance.

Timeline

Start
2008-10
Primary completion
2010-01
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Vandetanib Small molecule 300 mg Oral