Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT00064233
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2003-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2003-07-08', 'studyFirstSubmitQcDate': '2003-07-08', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chronic phase chronic myelogenous leukemia', 'relapsing chronic myelogenous leukemia', 'Philadelphia chromosome positive chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Cortes J, Sawyers CL, Kantarjian HM, et al.: Long-term efficacy of dasatinib in chronic-phase CML: results from the phase I trial (CA180002). [Abstract] Blood 110 (11): A-1026, 2007.'}, {'pmid': '16775234', 'type': 'RESULT', 'citation': "Talpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, Cortes J, O'Brien S, Nicaise C, Bleickardt E, Blackwood-Chirchir MA, Iyer V, Chen TT, Huang F, Decillis AP, Sawyers CL. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. doi: 10.1056/NEJMoa055229."}, {'type': 'RESULT', 'citation': 'Talpaz M, Kantarjian HM, Paquette R, et al.: A phase I study of BMS-354825 in patients with imatinib-resistant and intolerant chronic phase chronic myeloid leukemia (CML): results from CA180002. [Abstract] J Clin Oncol 23 (Suppl 16): A-6519, 564s, 2005.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: BMS-354825 may stop the growth of cancer cells by stopping the enzymes necessary for cancer cell growth.\n\nPURPOSE: This phase I trial is studying the side effects and best dose of BMS-354825 in treating patients with chronic phase chronic myelogenous leukemia that is resistant to imatinib mesylate.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the maximum tolerated dose, maximum administered dose, dose-limiting toxicity, and a recommended phase II dose of BMS-354825 in patients with chronic phase chronic myelogenous leukemia who have hematologic resistance to imatinib mesylate.\n* Determine the safety and tolerability of this drug in these patients.\n* Determine the plasma pharmacokinetics of this drug in these patients.\n* Determine, preliminarily, the efficacy of this drug, in terms of hematologic, cytogenetic, and molecular responses in these patients.\n\nOUTLINE: This is an open-label, dose-escalation, multicenter study.\n\nPatients receive oral BMS-354825 once daily on days 1-5. Courses repeat every 7 days for at least 3 months in the absence of disease progression or unacceptable toxicity. Patients may receive further treatment in the absence of disease progression.\n\nCohorts of 3-6 patients receive escalating doses of BMS-354825 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.\n\nOnce the MTD is determined, 20 additional patients receive treatment as in phase I at the MTD of BMS-354825.\n\nPatients are followed for at least 30 days.\n\nPROJECTED ACCRUAL: Approximately 50 patients (30 for phase I and 20 for phase II) will be accrued for this study within 12-18 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA:\n\n* Diagnosis of Philadelphia chromosome positive, chronic phase chronic myelogenous leukemia (CML) meeting all of the following criteria\\*:\n* Less than 15% blasts in peripheral blood and bone marrow\n* Less than 20% basophils in peripheral blood\n* Less than 30% blasts and promyelocytes in peripheral blood and bone marrow\n* Platelet count at least 100,000/mm\\^3 NOTE: \\*Patients who previously met the criteria for accelerated phase or blast phase CML, responded to treatment, and currently meet the criteria for chronic phase CML are eligible\n* Primary or acquired hematologic resistance to imatinib mesylate OR intolerance to imatinib mesylate defined as follows:\n* Primary hematologic resistance is defined as failure to reach complete hematologic response (CHR) with a dose of 400 mg/day continued for at least 3 months\n\n * Patients with hematological progression (i.e., WBC at least 10,000/mm\\^3 and rising consistently on at least 2 consecutive measurements obtained at least 14 days apart) while receiving imatinib mesylate of 400 mg/day are eligible if they have received less than 3 months of therapy\n* Acquired hematologic resistance is defined as achieving a CHR, but subsequently developing a rising WBC to at least 10,000/mm\\^3\n\n * WBC must be at least 10,000/mm\\^3 and rising on at least 2 measurements obtained at least 14 days apart with at least 1 of these measurements greater than 15,000/mm\\^3\n* Intolerance is defined as having discontinued imatinib mesylate due to nonhematologic toxicity of any grade\n\n * CD4\\^+ T-cell count at least 350/mm\\^3\n* 18 and over\n* ECOG 0-1\n* Life expectancy, At least 6 months.\n* Hepatic\n\n * Bilirubin no greater than 1.5 mg/dL\n * ALT and AST no greater than 2.0 times upper limit of normal (ULN)\n* Renal\n\n * Creatinine no greater than 1.5 times ULN\n * Potassium normal\\*\n * Magnesium normal\\*\n * Serum calcium or ionized calcium at least lower limit of normal NOTE: \\*Patients with low levels may be repleted to be eligible\n* Negative pregnancy test\n* Fertile patients must use effective contraception for 1 month before, during, and 1 month after study participation\n* More than 14 days since prior interferon\n* More than 14 days since prior cytarabine\n* More than 3 days since prior hydroxyurea\n* More than 28 days since other prior investigational or antineoplastic agents\n* More than 7 days since prior imatinib mesylate\n* At least 5 days or 5 half-lives since prior medications that inhibit platelet function, including the following:\n* Aspirin\n* Dipyridamole\n* Epoprostenol\n* Eptifibatide\n* Clopidogrel\n* Cilostazol\n* Abciximab\n* Ticlopidine\n* At least 5 days or 5 half-lives since prior anticoagulants such as warfarin or heparin/low molecular weight heparin (e.g., danaparoid, dalteparin, tinzaparin, enoxaparin)\n* At least 5 days or 5 half-lives since prior drugs accepted to have a risk of causing torsades de pointes, including the following:\n* Class IA antiarrhythmic agents (e.g., quinidine, procainamide, or disopyramide)\n* Class III antiarrhythmic agents (e.g., amiodarone, sotalol, ibutilide, or dofetilide)\n* Macrolide antibiotics (e.g., erythromycin or clarithromycin)\n* Antipsychotics (e.g., chlorpromazine, haloperidol, thioridazine, or pimozide)\n* Tricyclic antidepressants\n* Cisapride\n* Bepridil\n* Inapsine\n* Methadone\n* Arsenic\n* Concurrent anagrelide for thrombocytosis due to CML allowed\n\nExclusion Criteria:\n\n* extramedullary involvement (other than liver or spleen)\n* significant bleeding disorder unrelated to CML\n* acquired bleeding disorder within the past year (e.g., acquired antifactor VIII antibodies)\n* congenital bleeding disorders (e.g., von Willebrand disease)\n* uncontrolled or significant cardiovascular disease\n* uncontrolled angina within the past 6 months\n* congestive heart failure within the past 6 months\n* myocardial infarction within the past 12 months\n* history of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or torsades de pointes)\n* history of second or third degree heart block (may be eligible if patient has a pacemaker)\n* diagnosed or suspected congenital long QT syndrome\n* prolonged QTc interval on pre-entry EKG (i.e., greater than 450 msec)\n* heart rate less than 50/minute on pre-entry EKG\n* uncontrolled hypertension\n* vasculitis\n* pregnant or nursing\n* gastrointestinal tract bleeding within the past 6 months\n* connective tissue disorders\n* other serious uncontrolled medical disorder or active infection that would impair the ability to receive study therapy\n* dementia or altered mental status that would preclude giving informed consent\n* evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, EKG, or clinical laboratory determinations unrelated to CML\n* prisoners or patients who are compulsorily detained (e.g., involuntary incarceration for treatment of either a psychiatric or physical \\[e.g., infectious disease\\] illness)\n* concurrent drugs accepted to have a risk of causing torsades de pointes\n* other concurrent treatment for CML\n* concurrent dolasetron or droperidol\n* concurrent anticoagulants\n* concurrent medications that inhibit platelet function'}, 'identificationModule': {'nctId': 'NCT00064233', 'briefTitle': 'BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'A Phase I Dose-Escalation Study To Determine The Safety, Pharmacokinetics, And Pharmacodynamics Of BMS-354825 In The Treatment Of Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Hematologic Resistance To Imatinib Mesylate (Gleevec', 'orgStudyIdInfo': {'id': 'CDR0000310142'}, 'secondaryIdInfos': [{'id': 'UCLA-0303035'}, {'id': 'BMS-CA180002'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'dasatinib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Charles Sawyers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}