An Efficacy Study Comparing ZD6474 to Placebo in Medullary Thyroid Cancer

Phase 3 Completed 331 enrolled Genzyme, a Sanofi Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to learn how hereditary or sporadic medullary thyroid cancer patients, treated with ZD6474, react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474, and if ZD6474 can decrease or prevent the growth of tumors.

Timeline

Start: 2006-11-23
Primary completion: 2009-07-31
Completion: 2024-07-26

Outcome

Met primary endpoint

paper The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). PMID 22025146 ↗

release “Results from ZETA showed that treatment with vandetanib significantly extended progression-free survival, the primary endpoint of the study, in patients with advanced MTC.” astrazeneca.com ↗

Publications

Results Wells SA Jr, Robinson BG, Gagel RF, Dralle H, Fagin JA, Santoro M, Baudin E, Elisei R, Jarzab B, Vasselli JR, Read J, Langmuir P, Ryan AJ, Schlumberger MJ. Vandetanib in patients with locally advanced or metastatic medullary thyroid cancer: a randomized, double-blind phase III trial. J Clin Oncol. 2012 Jan 10;30(2):134-41. doi: 10.1200/JCO.2011.35.5040. Epub 2011 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vandetanib	Small molecule	300 mg	Oral