Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT00636259
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2008-06-11
First Post:
2008-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C053541', 'term': 'bicalutamide'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-06-10', 'studyFirstSubmitDate': '2008-03-07', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Prostate cancer', 'Casodex'], 'conditions': ['Adenocarcinoma of the Prostate']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with adenocarcinoma of the prostate\n* Subjects with locally advanced, and/or metastatic prostate cancer for whom surgical castration or other medical interventions are not considered appropriate or acceptable\n\nExclusion Criteria:\n\n* Any known history of abnormal liver function tests\n* Any severe concomitant condition that would make it undesirable, in the clinician's opinion, for the subject to participate in the trial.\n* Known hypersensitivity to bicalutamide or any of the components found in bicalutamide"}, 'identificationModule': {'nctId': 'NCT00636259', 'briefTitle': 'Casodex 150-mg Compassionate Use Trial for Subjects With Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Compassionate Use Trial With Bicalutamide (Casodex) 150-mg for Subjects With Prostate Cancer', 'orgStudyIdInfo': {'id': '7054US/0014'}, 'secondaryIdInfos': [{'id': 'D6874L00006'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Bicalutamide (Casodex)', 'type': 'DRUG', 'description': '150mg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}