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

Expanded access is no longer available for this treatment.
Information provided by AstraZeneca

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Descriptive Information Fields
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
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.

Detailed Description
Study Phase
Study Type  Expanded Access
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Adenocarcinoma of the Prostate
Intervention  Drug: Bicalutamide (Casodex)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  No longer available
Enrollment 
Start Date 
Completion Date
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
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers
Contacts ††
Location Countries 
Administrative Information Fields
NCT ID  NCT00636259
Organization ID 7054US/0014
Secondary IDs †† D6874L00006
Study Sponsor  AstraZeneca
Collaborators ††
Investigators 
Information Provided By AstraZeneca
Verification Date June 2008
First Received Date  March 7, 2008
Last Updated Date June 10, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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