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”

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.

Intervention(s) in this Clinical Trial

• Drug: Bicalutamide (Casodex)
  • 150mg

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 Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Investigator: AstraZeneca Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00636259

Study ID Number: 7054US/0014

ClinicalTrials.gov Identifier: NCT00636259

Health Authority: United States: Food and Drug Administration