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

NCT00659438 | Completed Phase 2 Results DMC

• 2 other identifiers: D4200C000802007-001891-35
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

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 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

Outcome Measures

Primary Outcomes (1)

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

  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)

  4 months

Secondary Outcomes (8)

• Progression Free Survival (PFS) at 4 Months (Instead of Time to PSA Progression)

  4 months

• Progression Free Survival (PFS) at 4 Months (Instead of Time to Onset of Cancer-related Symptoms)

  4 months

• PSA Response Rate

  4 months

• Overall Survival (OS)

  End of study (July 2011)

• Progression Rate From the Radionuclide Bone Scanning

  4 months

Study Arms (2)

1

EXPERIMENTAL

Bicalutamide 150mg + ZD6474 300mg

Drug: ZD6474 (Vandetanib); Drug: Bicalutamide

2

PLACEBO COMPARATOR

Bicalutamide 150mg + placebo

Drug: Bicalutamide; Drug: Placebo

Interventions

ZD6474 (Vandetanib) DRUG

300mg orally, once daily

Also known as: Zactima

1

Bicalutamide DRUG

150mg orally, once daily

Also known as: Casodex

1; 2

Placebo DRUG

orally, once daily

2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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).

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (5)

Research Site

Bordeaux, France

Location

Research Site

Créteil, France

Location

Research Site

Paris, France

Location

Research Site

Reims, France

Location

Research Site

Villejuif, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

vandetanib; bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 16, 2008
• Study Start: February 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: December 5, 2016
• Results First Posted: July 18, 2012

Record last verified: 2016-10

Locations

FR (5)