Status:
COMPLETED
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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 meta...
Eligibility Criteria
Inclusion
- Males presented with a confirmed histological diagnosis of adenocarcinoma of the prostate with evidence of metastases (including bone, lymph nodes, or other site) radiologically or histologically documented and despite a serum testosterone ≤1.73 nmol/L (50 ng/dL) proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA .
Exclusion
- Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding Visit 1. Incompletely healed surgical incision.
- Concomitant anticancer therapy other than surgical castration or continuous medical castration.
- Biology restriction.
- Clinical significant cardiovascular event or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- History of arrhythmia which is symptomatic or requires treatment (CTCAE grade 3), symptomatic despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled on medication are permitted.
- Hypertension not controlled by medical therapy
- ECG /QTc prolongation
- Presence of left bundle branch block (LBBB).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00659438
Start Date
February 1 2008
End Date
July 1 2011
Last Update
December 5 2016
Active Locations (5)
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1
Research Site
Bordeaux, France
2
Research Site
Créteil, France
3
Research Site
Paris, France
4
Research Site
Reims, France