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

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

Expanded access is no longer available for this treatment.
Information provided by AstraZeneca

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	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
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 ^†	Expanded Access
Study Design ^†
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Adenocarcinoma of the Prostate
Intervention ^†	Drug: Bicalutamide (Casodex)
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	No longer available
Enrollment ^†
Start Date ^†
Completion Date
Eligibility Criteria ^†	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 ^††
Location Countries ^†

Administrative Information Fields
NCT ID ^†	NCT00636259
Organization ID	7054US/0014
Secondary IDs ^††	D6874L00006
Study Sponsor ^†	AstraZeneca
Collaborators ^††
Investigators ^†
Information Provided By	AstraZeneca
Verification Date	June 2008
First Received Date ^†	March 7, 2008
Last Updated Date	June 10, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.