CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
ZD6474, Vandetanib +2 moredrug
Likely dose
ZD6474, Vandetanib 100 mgfrom 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/NCT00753714
NCT00753714Phase 2Completed
CompareCT.gov

Phase II, Randomised, Double-blind, Two-arm, Parallel Study of Vandetanib (ZACTIMA™ , ZD6474) Plus Gemcitabine (Gemzar® ) or Gemcitabine Plus Placebo as First Line Treatment of Advanced (Stage IIIB or IV) Non Small Cell Lung Cancer (NSCLC) Elderly Patients.

Genzyme, a Sanofi Company·interventional·Posted Sep 16, 2008·Updated Oct 17, 2016

In Brief

A Phase 2 clinical trial evaluating ZD6474, Vandetanib, Placebo to Match ZD6474, Vandetanib, and 1 other intervention for Non Small Cell Lung Cancer. Completed, enrolled 124 participants across 15 sites.

Detailed Summary

The primary objective of this study is to demonstrate an improvement in Progression-Free Survival (PFS) for the combination of vandetanib plus gemcitabine compared with gemcitabine plus placebo in chemonaïve (not including an adjuvant regimen) patients aged ≥ 70 years with advanced NSCLC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2008
Enrollment StartOct 1, 2008
Primary CompletionApr 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.8 years ago

Interventions

ZD6474, Vandetanibdrug

100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Placebo to Match ZD6474, Vandetanibdrug

100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first

Gemcitabinedrug

administered intravenously at 1200 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle UP to 6 cycles or UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first