Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-19 @ 11:36 PM
Study NCT ID:
NCT00569257
Status:
COMPLETED
Last Update Posted:
2011-12-13
First Post:
2007-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C080883', 'term': 'LHRH, lysine(6)-doxorubicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-12', 'studyFirstSubmitDate': '2007-12-06', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor response as per RECIST or (for Ovarian CA patients without evaluable target lesion following RECIST) GCIG criteria', 'timeFrame': 'up to six 3-weekly treatment cycles'}], 'secondaryOutcomes': [{'measure': 'Time-to-progression (TTP); Overall survival', 'timeFrame': 'up to observation of event'}, {'measure': 'Safety of AEZS-108 (possibly drug-related adverse events)', 'timeFrame': '4 weeks beyond last drug admnistration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LHRH receptor', 'receptor positive tumors', 'platinum resistant ovarian cancer'], 'conditions': ['Ovarian Cancer', 'Endometrial Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ago-ovar.de', 'label': 'AGO Studiengruppe Ovarialkarzinom'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)', 'detailedDescription': 'The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog.\n\nPatients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor\n* Histologically confirmed epithelial ovarian cancer (Stratum A)\n* Advanced (FIGO III or IV) or recurrent disease\n* Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen\n* Previous treatment with a taxane-containing regimen\n* At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria)\n* Histologically confirmed endometrial cancer (Stratum B)\n* Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy\n* No previous anthracycline-based chemotherapy\n* At least one measurable target lesion according to RECIST criteria'}, 'identificationModule': {'nctId': 'NCT00569257', 'briefTitle': 'Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'AEterna Zentaris'}, 'officialTitle': 'Antitumoral Activity and Safety of AEZS-108 (AN-152), a LHRH Agonist Linked Doxorubicin, in Women With LHRH Receptor Positive Gynecological Tumors', 'orgStudyIdInfo': {'id': 'AEZS-108-040'}, 'secondaryIdInfos': [{'id': 'AGO-GYN 5'}, {'id': 'EudraCT No. 2007-002663-26'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'AEZS-108', 'type': 'DRUG', 'otherNames': ['AN-152'], 'description': 'intravenous infusion at a dose of 267 mg/sqm every 3 weeks, up to 6 treatment cycles'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BG-5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'University Hospital "Dr. Georgy Stranski"', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': 'BG-4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Regional Oncology Hospital Plovdiv', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': 'BG-9010', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'Regional Oncodispensary "M.Markov"', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': 'D-13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinik für Frauenheilkunde und Geburtshilfe, Charité Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-28177', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Frauenklinik, Klinikum Bremen-Mitte GmbH', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': 'D-01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Klinik für Frauenheilkunde und Geburtshilfe, Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': 'D-91094', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Klinik für Frauenheilkunde, Universität Erlangen-Nürnberg', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsfrauenklinik, Universitätsklinikum', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': 'D-60591', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Universitätsfrauenklinik, Klinikum der JWG Universität Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': 'D-37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Frauenklinik, Georg-August-Universität Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': 'D-17487', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Klinikum der Ernst-Moritz-Arndt-Universitaet, Klinik und Poliklinik fuer Gynaekologie und Geburtshilfe', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': 'D-30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Frauenklinik, Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-76135', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Frauenklinik, St. Vincentius Kliniken AG', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': 'D-24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Klinik für Gynäkologie und Geburtshilfe, Universitätsklinikum Schleswig-Holstein, Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': 'D-21339', 'city': 'Lüneburg', 'country': 'Germany', 'facility': 'Frauenklinik, Klinikum Lüneburg', 'geoPoint': {'lat': 53.2509, 'lon': 10.41409}}, {'zip': 'D-18059', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Klinikum Suedstadt der Hansestadt Rostock, Universitaetsfrauenklinik und Poliklinik', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'D-65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'Klinik f. Gynäkologie u. Gyn. Onkologie, Dr. Horst Schmidt Kliniken GmbH', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Günter Emons, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäts-Frauenklinik / Department of Obstetrics and Gynecology, University of Göttingen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AEterna Zentaris', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AGO Study Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}