Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT00328120
Status:
COMPLETED
Last Update Posted:
2010-11-17
First Post:
2006-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Faslodex 500mg Multiple Dose Tolerability Study in BC Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-16', 'studyFirstSubmitDate': '2006-05-18', 'studyFirstSubmitQcDate': '2006-05-18', 'lastUpdatePostDateStruct': {'date': '2010-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of this study is to assess the tolerability of 500mg fulvestrant', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'each visit'}, {'measure': 'Time to progression', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}, {'measure': 'ORR', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}, {'measure': 'Time to response', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}, {'measure': 'duration of response and changes in serum tumour markers', 'timeFrame': 'assessed when all patients have been in the study for 6 months'}]}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'Faslodex'], 'conditions': ['Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent\n* Postmenopausal woman who fulfils any one of the following criteria:\n* Histological or cytological confirmation of breast cancer\n* Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).\n\nExclusion Criteria:\n\n* Having received any one of the following therapy for advanced or recurrent breast cancer\n* 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc'}, 'identificationModule': {'nctId': 'NCT00328120', 'briefTitle': 'Faslodex 500mg Multiple Dose Tolerability Study in BC Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer', 'orgStudyIdInfo': {'id': 'D6995C00004'}, 'secondaryIdInfos': [{'id': '9238IL/0062'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Fulvestrant', 'type': 'DRUG', 'otherNames': ['Faslodex', 'ZD9238'], 'description': '500 mg intramuscular injection'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'city': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Nagoyata', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Breast Cancer Established Brands Team Medical Science Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}