Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-24 @ 5:58 AM
Study NCT ID:
NCT00663832
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2008-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2008-04-18', 'studyFirstSubmitQcDate': '2008-04-21', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC', 'timeFrame': 'determine if MTD occurs after every 3 - 6 pts'}], 'secondaryOutcomes': [{'measure': 'To compare the PK profile of i.v. LBH589 with and without docetaxel', 'timeFrame': 'PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase'}, {'measure': 'To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC', 'timeFrame': 'PK assessment will occur during the first 2 weeks of each pt treatment'}, {'measure': 'To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone', 'timeFrame': 'PK assessment will occur during the first 2 weeks of each pt treatment'}]}, 'conditionsModule': {'keywords': ['Male', 'Prostate', 'Cancer', 'HRPC', 'DACi'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7783', 'label': 'Results for CLBH589C2205 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* HRPC patients\n* Evidence of disease progression\n* Self care, able to perform light work activities\n* Willing to use contraception throughout the study and for 12 weeks after study completion\n\nExclusion criteria:\n\n* History of other cancers not curatively treated with no evidence of disease for more than 5 years.\n* Prior radiotherapy within 3 weeks of starting study treatment\n* Prior radiopharmaceuticals (strontium, samarium).\n* Impaired cardiac function\n* Heart disease\n* Liver or renal disease with impaired functions.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00663832', 'briefTitle': 'A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'CLBH589C2205'}, 'secondaryIdInfos': [{'id': '2007-003315-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LBH589', 'interventionNames': ['Drug: LBH589 (i.v. panobinostat)']}], 'interventions': [{'name': 'LBH589 (i.v. panobinostat)', 'type': 'DRUG', 'otherNames': ['Panobinostat'], 'description': 'i.v. LBH589 dose levels: 10, 15, or 20 mg/m2\n\ni.v. docetaxel 75 or 60 mg/m2\n\noral prednisone 5mg bid.\n\nLBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle', 'armGroupLabels': ['LBH589']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89135', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': 'V5Z 1L8', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}