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

Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Prostate

Intervention: Bicalutamide (Casodex) (Drug)

Phase: N/A

Status: No longer available

Sponsored by: AstraZeneca

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.

Clinical Details

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

Study design: N/A

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Additional Information


Last updated: June 10, 2008

Page last updated: June 20, 2008

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