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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 Identifier:
First received: March 7, 2008
Last updated: June 10, 2008
Last verified: June 2008

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)

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Intervention Details:
    Drug: Bicalutamide (Casodex)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided Identifier: NCT00636259     History of Changes
Other Study ID Numbers: 7054US/0014, D6874L00006
Study First Received: March 7, 2008
Last Updated: June 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014