Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-08 @ 3:41 PM
Study NCT ID:
NCT00543205
Status:
TERMINATED
Last Update Posted:
2011-11-07
First Post:
2007-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C408162', 'term': 'oblimersen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Terminated due to very slow enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-04', 'studyFirstSubmitDate': '2007-10-10', 'studyFirstSubmitQcDate': '2007-10-10', 'lastUpdatePostDateStruct': {'date': '2011-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of G3139', 'timeFrame': '6-day period'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': '30 days post last dose of study medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Advanced Melanoma and Normal or Impaired', 'Hepatic Function']}, 'descriptionModule': {'briefSummary': 'This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of malignant melanoma\n* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable\n* ECOG Performance status of 0,1,or 2\n* Adequate venous access\n* Agreement to practice effective methods of birth control\n* Hepatically impaired consistent with Child-Pugh classification Grade B\n\nExclusion Criteria:\n\n* Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites\n* Prior organ allograft\n* Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy\n* Known hypersensitive to DTIC\n* Prior treatment with Genasense'}, 'identificationModule': {'nctId': 'NCT00543205', 'briefTitle': 'Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function', 'orgStudyIdInfo': {'id': 'GPK103'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genasense® (G3139, oblimersen sodium)', 'type': 'DRUG', 'otherNames': ['G3139', 'Oblimersen', 'Oblimersen sodium'], 'description': 'Genasense 7 mg/kg/day for 5 days'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genta Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}