Last reviewed · How we verify

NCT00777179

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

Completed Phase 2 Results posted Last updated 29 August 2016
What this trial tests

Phase 2 trial testing Vandetanib in NSCLC in 117 participants. Completed in 1 December 2011.

Timeline
1 October 2008
Primary endpoint
1 January 2010
1 December 2011

Quick facts

Lead sponsorGenzyme, a Sanofi Company
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment117
Start date1 October 2008
Primary completion1 January 2010
Estimated completion1 December 2011
Sites5 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Genzyme, a Sanofi Company — full company profile →

Who can join

18 and older, any sex, with NSCLC. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Single-agent maintenance therapy for advanced non-small cell lung cancer (NSCLC): a systematic review and Bayesian network meta-analysis of 26 randomized controlled trials.
    Wang Q, Huang H, Zeng X, Ma Y, et al · · 2016 · cited 9× · PMID 27781159 · DOI 10.7717/peerj.2550
  2. Current status of vandetanib (ZD6474) in the treatment of non-small cell lung cancer.
    Flanigan J, Deshpande H, Gettinger S. · · 2010 · cited 9× · PMID 20859451 · DOI 10.2147/btt.s7223

Verify or expand the search:

Other trials of Vandetanib

Trials testing the same drug.

Other recruiting trials for NSCLC

Currently open trials in the same condition.

Other Genzyme, a Sanofi Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00777179.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing