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

Expanded access is no longer available for this treatment.

First Received: March 7, 2008 Last Updated: June 10, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00636259

Purpose

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.

Condition	Intervention
Adenocarcinoma of the Prostate	Drug: Bicalutamide (Casodex)

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Study Type:	Expanded Access
Official Title:	A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer

Further study details as provided by AstraZeneca:

Intervention Details:

150mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	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

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Study ID Numbers:	7054US/0014, D6874L00006
Study First Received:	March 7, 2008
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00636259 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Prostate cancer
Casodex

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Hormones

Carcinoma
Androgen Antagonists
Bicalutamide
Adenocarcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial
Androgens

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions

Carcinoma
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Adenocarcinoma
Prostatic Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009