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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00636259
First received: March 7, 2008
Last updated: June 10, 2008
Last verified: June 2008
History of Changes
  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)

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:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Intervention Details:
    Drug: Bicalutamide (Casodex)
    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

ClinicalTrials.gov 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
Casodex

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

ClinicalTrials.gov processed this record on May 23, 2013