Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-26 @ 6:07 AM
Study NCT ID:
NCT00905593
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2012-07-18
First Post:
2009-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D001752', 'term': 'Blast Crisis'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002471', 'term': 'Cell Transformation, Neoplastic'}, {'id': 'D063646', 'term': 'Carcinogenesis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C498826', 'term': 'nilotinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'APPROVED_FOR_MARKETING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['chronic myeloid leukemia,', 'blast crisis,', 'accelerated phase,', 'nilotinib,', 'imatinib,', 'resistant,', 'intolerant,', 'chronic phase'], 'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on \\[CAMN107A2109\\] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having participated in Novartis study CAMN107A2109, and\n* Written signed and dated informed consent prior to any study procedures being performed.\n\nExclusion Criteria:\n\n* Impaired cardiac function,\n* Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,\n* Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,\n* patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,\n* Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR\n* Patients unwilling or unable to comply with the protocol.\n\nOther protocol -defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00905593', 'acronym': 'ENACT', 'briefTitle': 'Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase', 'orgStudyIdInfo': {'id': 'CAMN107AMX01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nilotinib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guadalajara, Jalisco', 'country': 'Mexico', 'facility': 'Novartis Investigative Site'}, {'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}