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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Adenocarcinoma of the Prostate

Keywords

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Prostate cancer Casodex

Interventions

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Bicalutamide (Casodex)

150mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Other Identifiers

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D6874L00006

Identifier Type: -

Identifier Source: secondary_id

7054US/0014