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

Sponsor
AstraZeneca (Industry)
Overall Status
No longer available
CT.gov ID
NCT00636259
Collaborator
(none)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bicalutamide (Casodex)

Study Design

Study Type:
Expanded Access
Official Title:
A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AstraZeneca

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00636259
    Other Study ID Numbers:
    • 7054US/0014
    • D6874L00006
    First Posted:
    Mar 14, 2008
    Last Update Posted:
    Jun 11, 2008
    Last Verified:
    Jun 1, 2008
    Keywords provided by , ,
    Prostate cancer
    Casodex
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Bicalutamide

    Study Results

    No Results Posted as of Jun 11, 2008