Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT00493766
Status:
TERMINATED
Last Update Posted:
2020-12-19
First Post:
2007-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital 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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Because of a strategic decision by Novartis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2007-06-26', 'studyFirstSubmitQcDate': '2007-06-26', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.', 'timeFrame': 'at study start and at study end'}, {'measure': '• To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC.', 'timeFrame': 'at study start and at study end'}], 'secondaryOutcomes': [{'measure': '• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities', 'timeFrame': 'at study start and at study end'}, {'measure': '• To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589.', 'timeFrame': 'at study start and at study end'}]}, 'conditionsModule': {'keywords': ['LBH589', 'Prostate Cancer', 'HRPC', 'Hormone Refractory Prostate Cancer'], 'conditions': ['Hormone Refractory Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2939', 'label': 'Results for CLBH589B2105 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Histologically documented adenocarcinoma of the prostate.\n* Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry.\n* Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment\n* Patients must be able to provide written informed consent\n\nExclusion criteria:\n\n* Patients with prior or concurrent brain metastases\n* Impaired cardiac, gastrointestinal, kidney, or liver function\n* Use of therapeutic androgens\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00493766', 'briefTitle': 'Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)', 'orgStudyIdInfo': {'id': 'CLBH589B2105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'oral LBH589 alone', 'interventionNames': ['Drug: LBH589']}, {'type': 'EXPERIMENTAL', 'label': 'oral LBH589 + IV docetaxel + oral prednisone', 'interventionNames': ['Drug: LBH589']}], 'interventions': [{'name': 'LBH589', 'type': 'DRUG', 'armGroupLabels': ['oral LBH589 + IV docetaxel + oral prednisone', 'oral LBH589 alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115-6-84', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washing University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Cancer Institute', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}