Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00057720
Status:
COMPLETED
Last Update Posted:
2011-07-25
First Post:
2003-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D019772', 'term': 'Topotecan'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 440}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-05', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-21', 'studyFirstSubmitDate': '2003-04-07', 'studyFirstSubmitQcDate': '2003-04-07', 'lastUpdatePostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['ovary'], 'conditions': ['Ovarian Neoplasms']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria include:\n\n* Considered platinum refractory or resistant according to standard criteria\n* Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin\n* Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer\n* Measurable disease according to RECIST criteria with documented tumor progression\n\nExclusion criteria include:\n\n* Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin\n* History of whole pelvis radiation therapy within 12 months of enrollment\n* Clinically significant cardiac disease\n* Evidence of gross hematuria at the time of study entry\n* Any signs of intestinal obstruction interfering with nutrition at the time of study entry\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00057720', 'briefTitle': 'TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer', 'nctIdAliases': ['NCT00078884'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Telik'}, 'officialTitle': 'Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]', 'orgStudyIdInfo': {'id': 'TLK286.3017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TLK286 HCl for injection', 'type': 'DRUG'}, {'name': 'topotecan hydrochloride for injection', 'type': 'DRUG'}, {'name': 'doxorubicin HCl liposome injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Hematology Oncology Associates', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91706', 'city': 'Baldwin Park', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Permanente Medical Group', 'geoPoint': {'lat': 34.08529, 'lon': -117.9609}}, {'zip': '91505-4866', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 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