NCT00659438

Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer

A Randomized, Double-blind Phase II Trial to Assess the Efficacy and Safety of Bicalutamide (Casodex® ) Associated to ZD6474 (Zactima™ ) or to Placebo in Patients With Castration-refractory Metastatic Prostate Cancer Without Any Clinical Symptom Related to Disease Progression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	ZD6474 (Vandetanib)	300mg orally, once daily
DRUG	Bicalutamide	150mg orally, once daily
DRUG	Placebo	orally, once daily

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-11-01
• Completion: 2011-07-01
• First posted: 2008-04-16
• Last updated: 2016-12-05
• Results posted: 2012-07-18

Locations

5 sites across 1 country: France