Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 4:29 AM
Study NCT ID:
NCT00129168
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2005-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C095179', 'term': 'zosuquidar trihydrochloride'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D003561', 'term': 'Cytarabine'}], 'ancestors': [{'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-28', 'studyFirstSubmitDate': '2005-08-09', 'studyFirstSubmitQcDate': '2005-08-09', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Leukemia, Myeloid', 'Relapse', 'Chemotherapy', 'Zosuquidar', 'Daunorubicin', 'Cytarabine', 'Acute', 'AML', 'Adult AML'], 'conditions': ['Leukemia, Myeloid']}, 'referencesModule': {'references': [{'pmid': '38407601', 'type': 'DERIVED', 'citation': 'Marcelletti JF, Sikic BI. Continuous 72-h infusion of zosuquidar with chemotherapy in patients with newly diagnosed acute myeloid leukemia stratified for leukemic blast P-glycoprotein phenotype. Cancer Chemother Pharmacol. 2024 Jun;93(6):595-604. doi: 10.1007/s00280-024-04656-6. Epub 2024 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'Chemotherapy drugs use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar in treating acute myeloid leukemia.', 'detailedDescription': 'Purpose:\n\nPhase I:\n\nTo Evaluate the safety of different doses of zosuquidar.\n\nPhase II:\n\nThis study is designed to study the safety and effectiveness of zosuquidar when given with daunorubicin and cytarabine in newly diagnosed AML patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed acute myeloid leukemia\n* Ages 55-75 years\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (FAB M3)\n* Patients must not have received prior chemotherapy for AML.\n* Prior exposure to anthracycline\n* Use of any investigational agent within 4 weeks prior to enrollment into the study\n\nFor Phase II:\n\n* Patients must be P-glycoprotein positive'}, 'identificationModule': {'nctId': 'NCT00129168', 'briefTitle': 'Zosuquidar in Combination With Daunorubicin and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia (AML)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kanisa Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Phase I/II, Multicenter Dose Escalation Study of Zosuquidar, Daunorubicin, and Cytarabine in Patients Ages 55-75 With Newly Diagnosed Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'KAN-979-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Zosuquidar', 'type': 'DRUG'}, {'name': 'Daunorubicin', 'type': 'DRUG'}, {'name': 'Cytarabine', 'type': 'DRUG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanisa Pharmaceuticals', 'class': 'INDUSTRY'}}}}