Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT00635856
Status:
COMPLETED
Last Update Posted:
2009-04-23
First Post:
2008-03-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label Trial to Assess Iressa in Prostate Cancer Patients
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': 'D000077156', 'term': 'Gefitinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-22', 'studyFirstSubmitDate': '2008-03-07', 'studyFirstSubmitQcDate': '2008-03-13', 'lastUpdatePostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Prostate Specific Antigen', 'timeFrame': 'Monthly'}], 'secondaryOutcomes': [{'measure': 'Duration of PSA decline', 'timeFrame': 'Monthly'}, {'measure': 'Safety variables', 'timeFrame': 'Monthly'}, {'measure': 'Time to Progression', 'timeFrame': 'Every 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Iressa', 'Gefitinib', 'Prostate Cancer', 'PSA'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "A study to assess the activity of Iressa in patients who's prostate cancer has recurred, and who have rising PSA levels"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prostate cancer diagnosis\n* no evidence of metastasis\n* Age 18 or older\n\nExclusion Criteria:\n\n* Prior chemotherapy for recurrent prostate cancer\n* Radiotherapy completed within 28 days of starting the study\n* Incomplete healing from prior cancer or other major surgery'}, 'identificationModule': {'nctId': 'NCT00635856', 'briefTitle': 'Open Label Trial to Assess Iressa in Prostate Cancer Patients', 'nctIdAliases': ['NCT00033579'], 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Phase II, Open-Label Trial to Assess the Activity of ZD1839 (IRESSA TM) in Patients With Recurrent Prostate Cancer Who Have Rising Serum PSA Levels Despite Serum Testosterone < 50mg/dl', 'orgStudyIdInfo': {'id': '1839US/0040'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gefitinib', 'type': 'DRUG', 'description': 'Iressa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Alison Armour Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}