Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-02-22 @ 6:43 PM
Study NCT ID:
NCT00708292
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2008-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'C528044', 'term': '5-(2,4-dihydroxy-5-isopropylphenyl)-4-(4-morpholin-4-ylmethylphenyl)isoxazole-3-carboxylic acid ethylamide'}, {'id': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'dispFirstSubmitDate': '2012-05-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2008-06-27', 'dispFirstSubmitQcDate': '2012-05-01', 'studyFirstSubmitQcDate': '2008-07-01', 'dispFirstPostDateStruct': {'date': '2012-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-07-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The safe dose of AUY922 when administered once a week.', 'timeFrame': '54 weeks (Maximum Tolerated Dose (MTD))'}], 'secondaryOutcomes': [{'measure': 'The safe dose of AUY922 when administered once a week in combination with bortezomib and dexamethasone.', 'timeFrame': '24 weeks (MTD determination of dual and triple combination)'}, {'measure': 'Efficacy of AUY922 administered once a week alone and in combination', 'timeFrame': 'at baseline and every 2 cycles (time to document tumor progression)'}]}, 'conditionsModule': {'keywords': ['AUY922', 'Multiple Myeloma', 'HSP90 inhibitors', 'Phase I/II'], 'conditions': ['Relapsed or Refractory Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '25809731', 'type': 'DERIVED', 'citation': 'Seggewiss-Bernhardt R, Bargou RC, Goh YT, Stewart AK, Spencer A, Alegre A, Blade J, Ottmann OG, Fernandez-Ibarra C, Lu H, Pain S, Akimov M, Iyer SP. Phase 1/1B trial of the heat shock protein 90 inhibitor NVP-AUY922 as monotherapy or in combination with bortezomib in patients with relapsed or refractory multiple myeloma. Cancer. 2015 Jul 1;121(13):2185-92. doi: 10.1002/cncr.29339. Epub 2015 Mar 24.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6904', 'label': 'Results for CAUY922A2103 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase I-Ib/II, open-label, multicenter study of AUY922 administered intravenously in patients with multiple myeloma to determine the maximum tolerated dose. The Phase II part will investigate the efficacy of AUY922 in patients with multiple myeloma. Additionally, the study includes a Phase Ib combination part of AUY922 administered in combination with bortezomib, to determine the maximum tolerated dose of the combination drugs in patients with multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients must have a diagnosis of active multiple myeloma.\n* Phase I and Phase II part: Patients must have received at least 2 but not more than 4 prior line of therapy and their disease has progressed during or after last therapy.\n* Phase Ib part: Patients must have received no more than 2 prior lines of therapy (excluding dexamethasone as single agent).\n* ECOG Performance Status of ≤ 2.\n* Patients must have acceptable neutrophil and platelet counts as well as adequate kidney and liver function.\n* Patients must have magnesium levels above lower limit of normal or correctable with supplements.\n* Patients must be willing and able to undergo bone marrow biopsy/aspirate.\n* Able to sign informed consent.\n\nExclusion criteria:\n\n* Prior treatment with any HSP90 or HDAC inhibitor for the treatment of multiple myeloma.\n* Patients with unresolved diarrhea ≥ CTCAE grade 2.\n* Patients with acute or chronic liver disease.\n* Patients using medications that have a relative risk of prolonging the QT interval.\n* Clinically significant cardiac diseases.\n* Patients with known disorders due to a deficiency in bilirubin glucuronidation (e.g. Gilbert's syndrome).\n* Pregnant or lactating women.\n* Fertile women of childbearing potential (WCBP) not using adequate contraception.\n* Male patients whose partners are WCBP, not using adequate contraception.\n* Patients who unwilling or unable to comply with the protocol.\n* Phase Ib part: Peripheral neuropathy ≥ CTCAE grade 1.\n* Phase Ib part: Prior treatment with bortezomib.\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT00708292', 'briefTitle': 'A Phase I-Ib/II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 Alone and in Combination With Bortezomib, With or Without Dexamethasone, in Patients With Relapsed or Refractory Multiple Myeloma.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Multi-center, Phase I-Ib/II Study of AUY922 Administered as Single Agent and in Combination With Bortezomib With or Without Dexamethasone in Adult Patients in Relapse or Refractory Multiple Myeloma.', 'orgStudyIdInfo': {'id': 'CAUY922A2103'}, 'secondaryIdInfos': [{'id': '2007-006279-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Agent AUY922', 'interventionNames': ['Drug: AUY922']}, {'type': 'EXPERIMENTAL', 'label': 'AUY922 + Bortezomib', 'interventionNames': ['Drug: AUY922', 'Drug: Bortezomib']}, {'type': 'EXPERIMENTAL', 'label': 'AUY922 + Bortezomib + Dexamethasone', 'interventionNames': ['Drug: AUY922', 'Drug: Bortezomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'AUY922', 'type': 'DRUG', 'armGroupLabels': ['AUY922 + Bortezomib', 'AUY922 + Bortezomib + Dexamethasone', 'Single Agent AUY922']}, {'name': 'Bortezomib', 'type': 'DRUG', 'armGroupLabels': ['AUY922 + Bortezomib', 'AUY922 + Bortezomib + Dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['AUY922 + Bortezomib + Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic - Arizona Cancer Clinical Research Unit', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(3)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3004', 'city': 'Melbourne', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '97070', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28006', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}