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

NCT00636259 | Unknown

• 2 other identifiers: 7054US/0014D6874L00006
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Prostate cancer; Casodex

Interventions

Bicalutamide (Casodex) DRUG

150mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Last Updated: June 11, 2008

Record last verified: 2008-06