Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-01-01 @ 4:52 AM
Study NCT ID:
NCT00728533
Status:
WITHDRAWN
Last Update Posted:
2011-03-18
First Post:
2008-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label, Randomised Parallel-Group Study
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': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Terminated due to awaiting data from Phase II study.', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'lastUpdateSubmitDate': '2011-03-17', 'studyFirstSubmitDate': '2008-01-18', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2011-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients.', 'timeFrame': '3-month'}], 'secondaryOutcomes': [{'measure': 'To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.', 'timeFrame': '3-month'}, {'measure': 'To evaluate pharmacokinetic response.', 'timeFrame': '3-month'}, {'measure': 'To compare safety and tolerability profiles of different degarelix three-month dosing regimens.', 'timeFrame': '3-month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate Cancer requiring Androgen Ablation Therapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Ablation Therapy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.\n* Screening testosterone level above the lower limit of normal range, globally defined as \\> 2.2 ng/mL.\n* Screening PSA level of =2 ng/mL. ECOG score of =2.\n* Life expectancy of at least one year.\n\nCRITERIA FOR EVALUATION:\n\nPrimary endpoint:\n\n* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.\n\nSecondary endpoints:\n\n* Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.\n* Serum levels of testosterone, LH, FSH, and PSA over time.\n* Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.\n* Plasma levels of degarelix over time.\n* Frequency and severity of adverse events.\n* Clinically significant changes in laboratory safety parameters.\n* Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.'}, 'identificationModule': {'nctId': 'NCT00728533', 'briefTitle': 'Open-Label, Randomised Parallel-Group Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ferring Pharmaceuticals'}, 'officialTitle': 'The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.', 'orgStudyIdInfo': {'id': 'FE200486 CS26'}, 'secondaryIdInfos': [{'id': '2007-006055-39'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '* Starting dose of 240 mg (40 mg/mL) will be given on Day 0.\n* Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months', 'interventionNames': ['Drug: Degarelix']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '* Starting dose of 240 mg (40 mg/mL) will be given on Day 0.\n* Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months.', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'description': 'Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.', 'armGroupLabels': ['1']}, {'name': 'Degarelix', 'type': 'DRUG', 'description': 'Prostate Cancer - Degarelix powder and solvent for suspension for injection. Three-month depot in two dosing regimens.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Clinical Development Support', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ferring Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ferring Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Development Support', 'oldOrganization': 'Ferring Pharmaceuticals'}}}}