Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-10 @ 2:37 PM
Study NCT ID:
NCT00586651
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D013920', 'term': 'Thrombocythemia, Essential'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D013922', 'term': 'Thrombocytosis'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119379', 'term': 'lestaurtinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2013-08-22', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2007-12-21', 'dispFirstSubmitQcDate': '2013-08-22', 'studyFirstSubmitQcDate': '2007-12-21', 'dispFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether a specific reduction in the JAK2 V617F allele has been indicated in this study.', 'timeFrame': '18 weeks +'}], 'secondaryOutcomes': [{'measure': '- improvements in hemoglobin values, neutrophil count, and platelet count. - reduction in dose of hydroxyurea - reduction in splenic enlargement - rate of phlebotomy', 'timeFrame': '18 weeks +'}]}, 'conditionsModule': {'conditions': ['Polycythemia Vera', 'Essential Thrombocytosis']}, 'referencesModule': {'references': [{'pmid': '24903629', 'type': 'DERIVED', 'citation': 'Hexner E, Roboz G, Hoffman R, Luger S, Mascarenhas J, Carroll M, Clementi R, Bensen-Kennedy D, Moliterno A. Open-label study of oral CEP-701 (lestaurtinib) in patients with polycythaemia vera or essential thrombocythaemia with JAK2-V617F mutation. Br J Haematol. 2014 Jan;164(1):83-93. doi: 10.1111/bjh.12607. Epub 2013 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment in patients with Polycythemia Vera (PV) and patients with Essential Thrombocytosis (ET).', 'detailedDescription': 'This is an 18-week open-label, multicenter study to evaluate the efficacy and tolerability of CEP-701 (lestaurtinib) treatment at a dosage of 80 mg bid for 18 weeks (126 days) in patients with Polycythemia Vera (PV) who have abnormal baseline neutrophil counts or require hydroxyurea therapy and patients with Essential Thrombocytosis (ET) who require hydroxyurea therapy for disease control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient has polycythemia vera (PV) or essential thrombocytosis (ET).\n* The patient has a detectable JAK2 V617F mutation.\n* Patients with PV have at least 1 of the following risk factors:\n\n 1. neutrophil count greater than 7000/mm3\n 2. receiving hydroxyurea treatment\n* Patients with ET are receiving concomitant hydroxyurea.\n* The patient has an ECOG performance score of 0, 1, or 2.\n\nExclusion Criteria:\n\n* The patient has bilirubin levels or aspartate transaminases (AST) levels within exclusionary ranges.\n* patient has serum creatinine concentrations within exclusionary ranges.\n* patient has an untreated or progressive infection.\n* patient has any physical or psychiatric condition that may compromise participation in the study.\n* has a history of venous or arterial thrombosis within 6 months.\n* use of hydroxyurea has been initiated or escalated in the month prior to screening.\n* has active gastrointestinal ulceration or bleeding.\n* patient has used an investigational drug within the past 30 days.\n* patient is being treated with anagrelide.\n* patient has previously taken CEP-701 (lestaurtinib).\n* patient has hypersensitivity to CEP-701 (lestaurtinib) or any component of CEP-701 (lestaurtinib).\n* patient has received interferon within the past 30 days.'}, 'identificationModule': {'nctId': 'NCT00586651', 'briefTitle': 'Open-Label Study of Oral CEP-701 (Lestaurtinib) in Patients With Polycythemia Vera or Essential Thrombocytosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label Study of Oral CEP-701 in Patients With Polycythemia Vera or Essential Thrombocytosis With the JAK2 V617F Mutation', 'orgStudyIdInfo': {'id': 'C0701/2030/ON/US'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lestaurtinib', 'interventionNames': ['Drug: lestaurtinib']}], 'interventions': [{'name': 'lestaurtinib', 'type': 'DRUG', 'description': '60 mg bid - 120 mg bid for an 18 weeks (126 days) treatment duration', 'armGroupLabels': ['lestaurtinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Presbyterian-Cornell', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10128', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cephalon', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}