Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer
- Conditions
- Adenocarcinoma of the Prostate
- Registration Number
- NCT00636259
- Lead Sponsor
- AstraZeneca
- 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
Not available
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Male
- Target Recruitment
- Not specified
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
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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
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Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method