Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 5:51 PM
Study NCT ID:
NCT00104468
Status:
TERMINATED
Last Update Posted:
2008-01-17
First Post:
2005-02-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074908', 'term': 'troxacitabine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'whyStopped': 'Trial stopped June 2007', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-04'}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-14', 'studyFirstSubmitDate': '2005-02-28', 'studyFirstSubmitQcDate': '2005-02-28', 'lastUpdatePostDateStruct': {'date': '2008-01-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the recommended infusion schedule for the investigational new drug administered as a continuous infusion with regards to dose limiting toxicities.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic/pharmacodynamic profile, preliminary evidence of the anti-tumor activity.'}]}, 'conditionsModule': {'keywords': ['Single-arm, open-label, multi-center, dose escalation, continuous infusion, multi-dose, acute myeloid leukemia', 'Acute myelogenous leukemia (AML) that has been refractory to prior therapy and/or is unlikely to benefit from known therapies'], 'conditions': ['Acute Myelogenous Leukemia']}, 'referencesModule': {'references': [{'pmid': '12113049', 'type': 'BACKGROUND', 'citation': 'Giles FJ. Troxacitabine-based therapy of refractory leukemia. Expert Rev Anticancer Ther. 2002 Jun;2(3):261-6. doi: 10.1586/14737140.2.3.261.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase I, single-arm, open-label, multi-center study of rising doses of Troxatyl™ whose purpose is to determine the safety, tolerance, and pharmacokinetics, and to establish the recommended infusion schedule of Troxatyl™.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies.\n* Subjects must have adequate organ and immune function as indicated by the following laboratory values: \\*Creatinine clearance ≥5 L/hr (83mL/min), \\*Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), \\*AST(SGOT) and ALT(SGPT) ≤3 x ULN\n\nExclusion Criteria:\n\n* Clinical evidence of active central nervous system (CNS) leukemic involvement\n* Active and uncontrolled infection\n* Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment\n* Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up\n* Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse.\n* Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment.\n* Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew.'}, 'identificationModule': {'nctId': 'NCT00104468', 'briefTitle': 'Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Refractory Acute Myelogenous Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'SGX Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open-Label, Single-Arm, Multi-Center, Phase I Study of Troxatyl™ (Troxacitabine) Administered by Continuous Infusion in Subjects With Refractory Acute Myelogenous Leukemia', 'orgStudyIdInfo': {'id': 'SPD758-110'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Troxatyl™ (Cytotoxic Chemotherapeutic)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell Medical College, New York Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SGX Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}}}}