Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-20 @ 12:38 PM
Study NCT ID:
NCT02160951
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2014-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719080', 'term': 'LGH-447'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of dose limiting toxicities', 'timeFrame': '28 days', 'description': 'Estimate the maximum tolerated dose and/or recommended dose for expansion of LGH447 in Japanese patients'}], 'secondaryOutcomes': [{'measure': 'Number of patients with adverse events as a measure of safety and tolerability of LGH447', 'timeFrame': '28 days and till the end of the study, an average of 84 days', 'description': 'Adverse events, serious adverse events, changes in laboratory values, and electrocardiograms'}, {'measure': 'Pharmacokinetics profile of LGH447 and its metabolites if appropriate', 'timeFrame': 'Baseline, 0.5, 1, 2, 3, 4, 5, 6, 8, 24 hours on Cycle1Day1, 14 and 28 and baseline on Cycle2Day14 and Cycle3Day1', 'description': 'PK parameters such as AUC, Cmax, Tmax, T1/2. Cycle = 28 days'}, {'measure': 'Overall Response Rate', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}, {'measure': 'Disease control rate', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}, {'measure': 'Duration of Response', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days, from the first documented onset of confirmed PR or better response to the date of documented disease progression/relapse or death due to multiple myeloma', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}, {'measure': 'Progression Free Survival', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days, from start of treatment to the date of event defined as the first documented disease progression/relapse, or death due to any cause', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}, {'measure': 'Time to response', 'timeFrame': 'Every 28 days till the end of the study, an average of 84 days, from start of treatment until first documented best overall response', 'description': 'Describe any preliminary anti-cancer activity associated with LGH447 based on International Myeloma Working group Criteria with modification.'}]}, 'conditionsModule': {'keywords': ['Multiple Myeloma,', 'Phase I,', 'PIM,', 'Japanese patients,', 'LGH447'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '33638035', 'type': 'DERIVED', 'citation': 'Iida S, Sunami K, Minami H, Hatake K, Sekiguchi R, Natsume K, Ishikawa N, Rinne M, Taniwaki M. A phase I, dose-escalation study of oral PIM447 in Japanese patients with relapsed and/or refractory multiple myeloma. Int J Hematol. 2021 Jun;113(6):797-806. doi: 10.1007/s12185-021-03096-9. Epub 2021 Feb 27.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=15748', 'label': 'Results for CLGH447X1101 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label, dose escalation, Phase 1 study of oral LGH447 in Japanese patients with relapsed and/or refractory multiple myeloma for which no standard effective treatment options exist.\n\nThe study consists of a dose escalation part to estimate the maximum tolerated dose and/or the recommended dose for expansion and a dose expansion part to further assess safety and preliminary anti-cancer activity of LGH447 at the maximum tolerated dose and/or the recommended dose for expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Confirmed diagnosis of relapsed and/or refractory MM for which no standard effective treatment options exist.\n\nExclusion Criteria:\n\n-Uncontrolled cardiovascular condition, including ongoing cardiac arrhythmias, congestive heart failure, angina, or myocardial infarction within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT02160951', 'briefTitle': 'Dose Escalation Study of LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Multi-center, Open-label, Dose Escalation, Phase 1 Study of Oral LGH447 in Japanese Patients With Relapsed and/or Refractory Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'CLGH447X1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LGH447', 'description': 'LGH447, QD', 'interventionNames': ['Drug: LGH447']}], 'interventions': [{'name': 'LGH447', 'type': 'DRUG', 'description': 'LGH447, QD', 'armGroupLabels': ['LGH447']}]}, 'contactsLocationsModule': {'locations': [{'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'zip': '602-8566', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '701-1192', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}