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

Adenocarcinoma of the Prostate Clinical Trial

Official title:

A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT00636259
• Other study ID #: 7054US/0014
• Secondary ID: D6874L00006
• Status: No longer available
• Phase: N/A
• First received: March 7, 2008
• Last updated: June 10, 2008

Study information

• Verified date: June 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide (Casodex)
150mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca