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Trial record 1 of 1 for:    D4200C00055
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E3-Hormone Refractory Prostrate Cancer Taxotere Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498797
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : May 24, 2011
Last Update Posted : October 7, 2016
Genzyme, a Sanofi Company
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine whether treatment with Zactima (vandetanib) in combination with Docetaxel and Prednisolone is more effective than the standard Docetaxel and Prednisolone alone for prostate cancer, in patients with Hormone refractory prostate cancer who have not previously received chemotherapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Hormone Refractory Drug: Zactima (vandetanib) Drug: Docetaxel Drug: Prednisolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of Docetaxel (Taxotere)/Prednisolone/ZD6474 vs Docetaxel/Prednisolone/Placebo in Patients With Hormone Refractory Prostrate Cancer (HRPC)
Study Start Date : December 2005
Actual Primary Completion Date : July 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Docetaxel

Primary Outcome Measures :
  1. Prostate Specific Antigen (PSA) Response [ Time Frame: PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline ]
    Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response

Secondary Outcome Measures :
  1. Number of Patients With an Objective Disease Progression Event [ Time Frame: RECIST tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (21 July 2007 or up to 7 days in advance of DCO) ]
    Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of PSA
  • No previous chemotherapy although those patients that have received estramustine can enter the study provided the estramustine was stopped 3 weeks before dosing of study drug
  • screening PSA values >20ng/ml. this must be confirmed by two separate measurements at least 2 weeks apart

Exclusion Criteria:

  • Treatment within 4 weeks before randomization and/or whilst on study, treatment with the following: 1)non-approved or experimental drug, 2)treatment with a drug with similar mechanism of action to ZD6474
  • concurrent treatment with other anticancer agents, othr than docetaxel and prednisolone as defined in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498797

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Research site
Rio de Janeiro, Brazil
Research Site
Sao Paulo, Brazil
Research Site
Hamburg, Germany
Research Site
Hannover, Germany
Research Site
Kassel, Germany
Research Site
Tubingen, Germany
Research Site
Budapest, Hungary
South Africa
Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Umea, Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
Genzyme, a Sanofi Company
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi Identifier: NCT00498797     History of Changes
Other Study ID Numbers: D4200C00055
2005-003593-16 ( EudraCT Number )
First Posted: July 10, 2007    Key Record Dates
Results First Posted: May 24, 2011
Last Update Posted: October 7, 2016
Last Verified: August 2016

Keywords provided by Sanofi:
prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Methylprednisolone Acetate
Prednisolone acetate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents