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Efficacy and Safety Study of Vandetanib (ZD 6474) in Combination With Bicalutamide Versus Bicalutamide Alone in Patients With Chemotherapy Naive Hormone Refractory Prostate Cancer.

NCT00757692 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2013-02-20

No results posted yet for this study

Summary

Purpose To define the efficacy, tolerability and safety of Vandetanib in combination with bicalutamide in patients with chemotherapy naive hormone refractory prostate cancer

Hypothesis There will be a PSA response when Vandetanib is given in combination with Bicalutamide in Chemotherapy Naive Hormone refractory prostate cancer patients.

Conditions

Interventions

DRUG

Vandetanib

Vandetanib at 300 mg in combination with Bicalutamide at 50 mg will be administered orally, daily and continuously

DRUG

Bicalutamide

Bicalutamide at 50 mg will be administered orally, daily and continuously.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Kim Chi, MD · BC Cancer Agency - Vancouver Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-02-29
Completion
2012-11-30

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00757692 on ClinicalTrials.gov