Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2026-01-17 @ 9:26 PM
Study NCT ID:
NCT00641160
Status:
UNKNOWN
Last Update Posted:
2008-09-26
First Post:
2008-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-09-24', 'studyFirstSubmitDate': '2008-03-19', 'studyFirstSubmitQcDate': '2008-03-19', 'lastUpdatePostDateStruct': {'date': '2008-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as measured by adverse events, physical examinations, clinical laboratory assessments, and vital signs', 'timeFrame': 'Assessed at each subject visit to the study center'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of orally administered vinorelbine', 'timeFrame': 'Samples collected on Study Days 1, 2, and 8'}, {'measure': 'Exploratory analysis of blood markers of biological activity', 'timeFrame': 'Blood samples collected at selected subject visits to the study center'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vinorelbine', 'metronomic dosing', 'oral administration', 'nonhematologic malignancies', 'pharmacokinetics'], 'conditions': ['Nonhematologic Malignancies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. The study will be conducted in subjects with a non-hematologic malignancy for which there are no currently accepted therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* capable of understanding study requirements and able to provide Informed Consent\n* diagnosed with a non-hematologic malignancy for which there are no currently accepted therapies\n* life expectancy at least 3 months\n* agreement to use medically acceptable contraception throughout the study\n* willing and able to comply with the protocol requirements\n\nExclusion Criteria:\n\n* currently receiving systemic treatment for malignancy\n* not yet recovered from the toxicity of prior therapies\n* platelet count \\< 100,000 cells/mm3 within 7 days prior to study entry\n* ANC \\< 1500 cells/mm3 within 7 days prior to study entry\n* hemoglobin \\< 8.5 g/dL within 7 days prior to study entry\n* AST and/or ALT \\> 2.5 X ULN within 7 days prior to study entry\n* total bilirubin \\> 1.5 X ULN within 7 days prior to study entry\n* creatinine clearance \\< 60 mL/min (Cockroft-Gault formula) within 7 days prior to study entry\n* receipt of any investigational therapy within 3 weeks prior to study entry\n* known history of HIV, HBV, and/or HCV infection\n* clinically relevant active infection or serious co-morbid medical condition at study entry\n* major surgery within 4 weeks prior to study entry\n* other malignancy within 3 year prior to study entry\n* pregnant or breast-feeding\n* presence of a concomitant disease or condition which, in the opinion of the Investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk'}, 'identificationModule': {'nctId': 'NCT00641160', 'briefTitle': 'Safety Study of Oral Vinorelbine in Subjects With Non-Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metronome Therapeutics'}, 'officialTitle': 'A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies', 'orgStudyIdInfo': {'id': 'MT-CL002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'interventionNames': ['Drug: vinorelbine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'interventionNames': ['Drug: vinorelbine tartrate']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'interventionNames': ['Drug: vinorelbine tartrate']}], 'interventions': [{'name': 'vinorelbine tartrate', 'type': 'DRUG', 'description': 'Dose Level #1 PO for at least 7 days', 'armGroupLabels': ['Cohort 1']}, {'name': 'vinorelbine tartrate', 'type': 'DRUG', 'description': 'Dose Level #2 PO for at least 7 days', 'armGroupLabels': ['Cohort 2']}, {'name': 'vinorelbine tartrate', 'type': 'DRUG', 'description': 'Dose Level #3 PO for at least 7 days', 'armGroupLabels': ['Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology PA; Sammons Cancer Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'George Tidmarsh, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Metronome Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metronome Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'George Tidmarsh, MD, PhD', 'oldOrganization': 'Metronome Therapeutics'}}}}