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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


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


Inclusion Criteria:



- 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 Criteria:

- 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).

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months

Outcome Description:

To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : After decline from baseline: a 25% increase above the nadir No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)

Outcome Time Frame:

4 months

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

D4200C00080

NCT ID:

NCT00659438

Start Date:

February 2008

Completion Date:

July 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

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