CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 117 enrolled
Drug / intervention
Vandetanib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00777179
NCT00777179Phase 2Completed
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Randomized, Double-blinded, Placebo-controlled Phase II Study of Vandetanib (ZactimaTM) Maintenance for Locally Advanced or Metastatic Non-small-cell Lung Carcinoma (NSCLC) Following Platinum-doublet Chemotherapy

Genzyme, a Sanofi Company·interventional·Posted Oct 22, 2008·Updated Oct 10, 2016

In Brief

A Phase 2 clinical trial evaluating Vandetanib and Placebo for NSCLC. Completed, enrolled 117 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC
CountriesSouth Korea
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2008
Enrollment StartOct 1, 2008
Primary CompletionJan 1, 2010
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.7 years ago

Interventions

Vandetanibdrug

Tablet, oral, daily

Placebodrug

Placebo