Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-01-02 @ 8:38 AM
Study NCT ID:
NCT00097903
Status:
COMPLETED
Last Update Posted:
2020-03-12
First Post:
2004-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406143', 'term': 'cositecan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-10', 'studyFirstSubmitDate': '2004-12-01', 'studyFirstSubmitQcDate': '2004-12-01', 'lastUpdatePostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Safety and determination of MTD, and recommended Phase 2 dose', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'various timepoints'}, {'measure': 'Tumor response', 'timeFrame': 'various timepoints'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carcinoma, Non-Small-Cell Lung', 'Solid Tumors', 'Oral'], 'conditions': ['Carcinoma', 'Carcinoma, Non-Small-Cell Lung']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.', 'detailedDescription': 'Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.\n\nWhen the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.\n* Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.\n* Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.\n* Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.\n* Patients must have an ECOG performance status of less than or equal to 1.\n* More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from previous treatment with nitrosoureas or mitomycin-C.\n* Patients must have fully recovered from the toxic effects of prior therapy.\n* Patients entering the Phase 1 portion of the study may have received up to two prior chemotherapy programs including adjuvant or neoadjuvant therapy.\n* Patients entering the Phase 2 portion of the study may have received only one prior chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.\n* More than 2 weeks must have elapsed since previous radiation therapy and prior radiation must be less than or equal to 15% of the bone marrow.\n* Required Initial Laboratory Data: \\*ANC ≥ 1,500/mm3, \\*Platelet count ≥ 100,000/mm3, \\*SGPT \\< 1.5 times ULN, \\*Alkaline phosphatase \\< 2.0 times ULN, \\*Bilirubin \\< 1.5 mg/dl, \\*Serum creatinine \\< 1.5 times ULN\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.\n* Phase 2 no previous or concurrent malignancy\n* Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.\n* Active infection.\n* Known positive HIV status.\n* Conditions requiring use of H2 blockers or other antacids.\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT00097903', 'briefTitle': 'Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioNumerik Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase 1 Trial of Oral Karenitecin® in Patients With Solid Tumors"', 'orgStudyIdInfo': {'id': 'KTN22208'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Karenitecin IV/ Karenitecin tablet', 'interventionNames': ['Drug: Karenitecin (BNP1350)']}], 'interventions': [{'name': 'Karenitecin (BNP1350)', 'type': 'DRUG', 'otherNames': ['Karenitecin also referred to as BNP1350'], 'description': 'Phase 1 study,dose-escalation design', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioNumerik Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Crown Bioscience', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}