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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00636259
Recruitment Status : No longer available
First Posted : March 14, 2008
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Adenocarcinoma of the Prostate Drug: Bicalutamide (Casodex)

Study Design

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Interventions

Intervention Details:
    Drug: Bicalutamide (Casodex)
    150mg
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

ClinicalTrials.gov Identifier: NCT00636259     History of Changes
Other Study ID Numbers: 7054US/0014
D6874L00006
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by AstraZeneca:
Prostate cancer
Casodex

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents