Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-28 @ 10:38 PM
Study NCT ID:
NCT00503451
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077767', 'term': 'Panobinostat'}], 'ancestors': [{'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of LBH589 in the blood on days 1, 5, 8, 9 and 10 of first cycle', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety, tolerability and efficacy of oral LBH589 throughout the study', 'timeFrame': 'at least every 2 months'}]}, 'conditionsModule': {'keywords': ['Advanced cancer', 'solid tumors', 'lymphoma', 'HDAC', 'LBH589', 'adults', "non-Hodgkin's lymphoma"], 'conditions': ['Non-Hodgkin Lymphoma', 'Neoplasms']}, 'referencesModule': {'references': [{'pmid': '21706316', 'type': 'DERIVED', 'citation': 'Hamberg P, Woo MM, Chen LC, Verweij J, Porro MG, Zhao L, Li W, van der Biessen D, Sharma S, Hengelage T, de Jonge M. Effect of ketoconazole-mediated CYP3A4 inhibition on clinical pharmacokinetics of panobinostat (LBH589), an orally active histone deacetylase inhibitor. Cancer Chemother Pharmacol. 2011 Sep;68(3):805-13. doi: 10.1007/s00280-011-1693-x. Epub 2011 Jun 26.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4102', 'label': 'Results for CLBH589B2110 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Adequate kidney function and laboratory values\n\nExclusion criteria:\n\n* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago\n* Patients who had a heart attack or have unstable angina within past 6 months\n* Heart disease including congestive heart failure and uncontrolled high blood pressure\n* Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea\n* Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study\n* Female patients who are pregnant or breast feeding.\n\nOther protocol inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT00503451', 'briefTitle': 'A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IB, Study to Investigate the Effect of Ketoconazole, a CYP3A4 Inhibitor, on Oral LBH589 and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'CLBH589B2110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LBH589', 'interventionNames': ['Drug: LBH589']}], 'interventions': [{'name': 'LBH589', 'type': 'DRUG', 'otherNames': ['Panobinostat'], 'armGroupLabels': ['LBH589']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}