Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01630018
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2012-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019772', 'term': 'Topotecan'}, {'id': 'C116963', 'term': 'belotecan'}], 'ancestors': [{'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-20', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-06-26', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'approximately 21 days(every 1 Cycle)'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'up to 4 years'}, {'measure': 'Progression Free survival', 'timeFrame': 'up tp 4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epithelial Ovarian Cancer', 'Belotecan', 'Topotecan'], 'conditions': ['Epithelial Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '32994466', 'type': 'DERIVED', 'citation': 'Kim HS, Park SY, Park CY, Kim YT, Kim BJ, Song YJ, Kim BG, Kim YB, Cho CH, Kim JH, Song YS. A multicentre, randomised, open-label, parallel-group Phase 2b study of belotecan versus topotecan for recurrent ovarian cancer. Br J Cancer. 2021 Jan;124(2):375-382. doi: 10.1038/s41416-020-01098-8. Epub 2020 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy and safety of belotecan or topotecan in patients with recurrent or refractory ovarian cancer (AOC).', 'detailedDescription': 'A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan (CamtoBell inj.) or Topotecan in Patients with Recurrent or Refractory Ovarian Cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Histological or cytological diagnosis of AOC\n* Stable disease (SD) or progression at time of study entry Recurrent or progressive AOC ≥ 90 days of duration of response for first-line therapy\n* Measurable disease defined by RECIST criteria\n* ECOG Performance Status of 0, 1, or 2\n* Life expectancy \\> 3 months\n* Adequate bone marrow, Renal, Hepatic reserve:\n\n * absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/μL\n * platelet count ≥ 100,000 cells/μL\n * hemoglobin ≥ 9 g/dL\n * Total bilirubin ≤ 1.5 X ULN\n * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 X ULN\n * Alkaline Phosphatase (ALP) ≤ 2.0 X ULN\n * Serum creatinine \\< 1.5mg/dL or calculated creatinine clearance \\> 60mL/min\n* Signed a written informed consent\n\nExclusion Criteria:\n\n* Active infection\n* Symptomatic brain lesion\n* Any other type of cancer during the previous 5 years except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix Severe concurrent diseases\n* Prior anticancer therapy within 4 weeks before enroll\n* Active pregnancy test and Pregnant or nursing women\n* Participation in any investigational drug study within 28 days prior to study entry'}, 'identificationModule': {'nctId': 'NCT01630018', 'briefTitle': 'Belotecan Versus Topotecan for Recurrent Ovarian Cancer: A Randomized, Open-label, Parallel-group Phase IIb Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell Inj.) or Topotecan in Patients With Recurrent or Refractory Ovarian Cancer', 'orgStudyIdInfo': {'id': '11AOC09J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Topotecan', 'description': 'Topotecan', 'interventionNames': ['Drug: Topotecan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Camtobell', 'description': 'Belotecan', 'interventionNames': ['Drug: Belotecan']}], 'interventions': [{'name': 'Topotecan', 'type': 'DRUG', 'otherNames': ['Hycamtin inj.'], 'description': '1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression', 'armGroupLabels': ['Topotecan']}, {'name': 'Belotecan', 'type': 'DRUG', 'otherNames': ['Camtobell inj.'], 'description': '0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression', 'armGroupLabels': ['Camtobell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul Metropolitan', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong-Sang Song, phD, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}