Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-04-09 @ 10:48 AM
Study NCT ID:
NCT00542893
Status:
COMPLETED
Last Update Posted:
2012-03-13
First Post:
2007-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C408162', 'term': 'oblimersen'}, {'id': 'D003606', 'term': 'Dacarbazine'}], 'ancestors': [{'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-11', 'studyFirstSubmitDate': '2007-10-10', 'studyFirstSubmitQcDate': '2007-10-10', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-12', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bcl-2', 'CFR', 'DTIC', 'ECOG', 'EMEA', 'MedDRA', 'NCI CTC', 'SAE'], 'conditions': ['Advanced Melanoma']}, 'descriptionModule': {'briefSummary': 'This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic Stage IV disease, or Stage III disease that is not surgically resectable\n* ECOG Performance Status of 0, 1, or 2\n* Life expectancy of at least 12 weeks\n* Adequate venous access\n* Agreement to practice effective method of birth control\n\nExclusion Criteria:\n\n* Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy\n* Significant medical disease\n* Known hypersensitivity to phosphorothioate-containing oligonucleotides\n* Known hypersensitivity to DTIC\n* Pregnancy/Lactation'}, 'identificationModule': {'nctId': 'NCT00542893', 'briefTitle': 'A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genta Incorporated'}, 'officialTitle': 'A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma', 'orgStudyIdInfo': {'id': 'GPK105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2', 'interventionNames': ['Drug: Genasense® (G3139, oblimersen sodium)', 'Drug: DTIC alone; then Genasense followed by DTIC']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2', 'interventionNames': ['Drug: Genasense® (G3139, oblimersen sodium)', 'Drug: Genasense followed by DTIC; then DTIC alone']}], 'interventions': [{'name': 'Genasense® (G3139, oblimersen sodium)', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Genasense followed by DTIC; then DTIC alone', 'type': 'DRUG', 'description': 'Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2', 'armGroupLabels': ['Group 2']}, {'name': 'DTIC alone; then Genasense followed by DTIC', 'type': 'DRUG', 'description': 'Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2', 'armGroupLabels': ['Group 1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genta Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}