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

AstraZeneca

Status

Conditions: Adenocarcinoma of the Prostate

Treatments: Drug: Bicalutamide (Casodex)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00636259

7054US/0014

D6874L00006

Details and patient eligibility

About

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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