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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   (Adult, Senior)
Sexes 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 Identifier: NCT00636259     History of Changes
Other Study ID Numbers: 7054US/0014
Study First Received: March 7, 2008
Last Updated: June 10, 2008

Keywords provided by AstraZeneca:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents processed this record on August 23, 2017