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Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

Primary Purpose

Adenocarcinoma of the Prostate

Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Bicalutamide (Casodex)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Adenocarcinoma of the Prostate focused on measuring Prostate cancer, Casodex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Male

Inclusion Criteria:

  • Patients with adenocarcinoma of the prostate
  • Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable

Exclusion Criteria:

  • Any known history of abnormal liver function tests
  • Any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial.
  • Known hypersensitivity to bicalutamide or any of the components found in bicalutamide

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2008
    Last Updated
    June 10, 2008
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00636259
    Brief Title
    Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer
    Official Title
    A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    No longer available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    This study provides compassionate use of bicalutamide (Casodex) at a 150-mg dose for subjects with prostate cancer prior to it becoming commercially available. The patient will receive bicalutamide 150-mg as long as the physician feels that the subject is benefiting from this therapy and safety information is provided regularly to AstraZeneca. Treatment will be discontinued after bicalutamide 150-mg becomes commercially available.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adenocarcinoma of the Prostate
    Keywords
    Prostate cancer, Casodex

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Bicalutamide (Casodex)
    Intervention Description
    150mg

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patients with adenocarcinoma of the prostate Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable Exclusion Criteria: Any known history of abnormal liver function tests Any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial. Known hypersensitivity to bicalutamide or any of the components found in bicalutamide

    12. IPD Sharing Statement

    Learn more about this trial

    Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer

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