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

Tracking Information
First Received Date ^ICMJE	March 7, 2008
Last Updated Date	June 10, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00636259 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer
Official Title ^ICMJE	A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer
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.
Detailed Description
Study Phase
Study Type ^ICMJE	Expanded Access
Study Design ^ICMJE
Condition ^ICMJE	Adenocarcinoma of the Prostate
Intervention ^ICMJE	Drug: Bicalutamide (Casodex)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	No longer available
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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	Male
Ages	18 Years and older
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00636259
Responsible Party
Study ID Numbers ^ICMJE	7054US/0014, D6874L00006
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	AstraZeneca
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP