Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 9:33 AM
Study NCT ID:
NCT00362466
Status:
TERMINATED
Last Update Posted:
2009-11-20
First Post:
2006-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], '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': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'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'}, {'id': 'D000068877', 'term': 'Imatinib Mesylate'}], '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'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'title': 'BMS Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated early due to insufficient enrollment.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Dasatinib', 'description': '100 mg once daily (QD)', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Imatinib', 'description': '600 mg QD', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Complete Cytogenetic Response (CCyR) Rate at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6', 'description': 'Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'Major Molecular Response (MMR) Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, Month 6, Month 12, Month 24 and Month 36', 'description': 'MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'CCyR Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, Month 12, Month 24 and Month 36', 'description': 'CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'Estimate Time to MMR and CCyR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'throughout the study', 'description': 'Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'at 36 months', 'description': 'PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to Discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Duration of CCyR and MMR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study', 'description': 'Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.', 'unitOfMeasure': 'months', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}, {'type': 'SECONDARY', 'title': 'Best MMR Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'OG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'paramType': 'NUMBER', 'timeFrame': 'throughout study', 'description': 'MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was not done. This study was terminated due to insufficient enrollment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dasatinib', 'description': '100 mg once daily (QD)'}, {'id': 'FG001', 'title': 'Imatinib', 'description': '600 mg QD'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 156 subjects were to be enrolled; however, the attempts were unsuccessful and the study was closed after 3 subjects were enrolled. A fourth subject underwent screening, but was not randomized since the subject did not meet the inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dasatinib', 'description': '100 mg QD'}, {'id': 'BG001', 'title': 'Imatinib', 'description': '600 mg QD'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'title': '30- to 39-years-old', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '40- to 49-years-old', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': '50- to 59-years-old', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Insufficient Enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-18', 'studyFirstSubmitDate': '2006-08-09', 'resultsFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2006-08-09', 'lastUpdatePostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-24', 'studyFirstPostDateStruct': {'date': '2006-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Cytogenetic Response (CCyR) Rate at Month 6', 'timeFrame': 'Month 6', 'description': 'Cytogenetic Response (CyR) is based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.'}], 'secondaryOutcomes': [{'measure': 'Major Molecular Response (MMR) Rates', 'timeFrame': 'Month 3, Month 6, Month 12, Month 24 and Month 36', 'description': 'MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as percent of ratio of BCR-ABL gene transcripts to the control gene. In this study,ABL was used as the control gene.'}, {'measure': 'CCyR Rates', 'timeFrame': 'Month 3, Month 12, Month 24 and Month 36', 'description': 'CyR is based on the prevalence of Ph+ metaphases among cells in metaphase on a bone marrow sample. The criteria for CCyR is 0% Ph+ metaphases among cells in a bone marrow sample.'}, {'measure': 'Estimate Time to MMR and CCyR', 'timeFrame': 'throughout the study', 'description': 'Time to MMR is defined as the time from first treatment dose until measurement criteria are first met for MMR. Time to MMR is computed only for subjects who achieved a MMR. Time to CCyR is defined as the time from first treatment dose until measurement criteria are first met for CCyR. Time to CCyR is computed only for subjects who achieved a CCyR.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'at 36 months', 'description': 'PFS=time from randomization until progression or death. Participants who died without progression=progression on date of death. Participants who neither progressed nor died were censored on date of last hematologic assessment. Participants who did not receive study treatment and neither progressed nor died were censored on date of randomization.'}, {'measure': 'Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to AEs', 'timeFrame': 'From 2 weeks prior to randomization through Month 36. At least every 4 weeks until all study-related toxicities resolve to baseline, stabilize, or are deemed irreversible.', 'description': 'An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.'}, {'measure': 'Duration of CCyR and MMR', 'timeFrame': 'Throughout the study', 'description': 'Duration of CCyR computed for subjects with CCyR as best response; measured from time the criteria are first met for CCyR until date of progression or death. Duration of MMR computed for subjects with MMR as best response; measured from time the criteria are first met for MMR until date the MMR was first lost, disease progression or death.'}, {'measure': 'Best MMR Rates', 'timeFrame': 'throughout study', 'description': 'MMR is defined as a 3-log reduction in BCR-ABL gene transcripts from a standardized baseline. Reductions in BCR-ABL transcripts on logarithmic scale are calculated based on the absolute values expressed as % of ratio of BCR-ABL gene transcripts to the control gene. In this study, ABL was used as the control gene.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leukemia (chronic myeloid leukemia - chronic phase)'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with imatinib 400 mg\n* Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis\n* Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2\n* Adequate hepatic and renal function\n\nExclusion Criteria:\n\n* Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant\n* Previous diagnosis of accelerated/blast crisis CML\n* Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases\n* Previous documentation of T315I mutation\n* Uncontrolled or significant cardiovascular disease\n* Serious uncontrolled medical disorder/active infection\n* History of significant bleeding disorder unrelated to CML\n* Intolerance to imatinib ≥400 mg\n* Concurrent malignancies other than CML'}, 'identificationModule': {'nctId': 'NCT00362466', 'briefTitle': 'A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-Label Randomized Phase III Study of Dasatinib vs. High-Dose (600 mg) Imatinib Mesylate in the Treatment of Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Are Imatinib Failures or Who Have Had a Suboptimal Response After 3-18 Months of Therapy With 400 mg Imatinib', 'orgStudyIdInfo': {'id': 'CA180-044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': '50-180 mg once daily (QD)', 'interventionNames': ['Drug: Dasatinib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': '200-800 mg QD', 'interventionNames': ['Drug: Imatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel®'], 'description': 'Tablets, Oral, Once daily, 5-7 years', 'armGroupLabels': ['A']}, {'name': 'Imatinib', 'type': 'DRUG', 'description': 'Tablets, Oral, Once daily, 5-7 years', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Dr. Marshall Schreeder', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91750', 'city': 'La Verne', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.10084, 'lon': -117.76784}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '41701', 'city': 'Hazard', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.24954, 'lon': -83.19323}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'New York Medical College', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution'}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29150', 'city': 'Sumter', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Santee Hematology/Oncology', 'geoPoint': {'lat': 33.92044, 'lon': -80.34147}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}