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

NCT ID: NCT00636259

Last Updated: 2008-06-11

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Adenocarcinoma of the Prostate

Interventions

Bicalutamide (Casodex)

150mg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Other Identifiers

D6874L00006

Identifier Type: -

Identifier Source: secondary_id

7054US/0014

Identifier Type: -

Identifier Source: org_study_id