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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT00636259
Enrollment
Unknown
Registered
2008-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2008-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenocarcinoma of the Prostate

Keywords

Prostate cancer, Casodex

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.

Interventions

DRUGBicalutamide (Casodex)

150mg

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026