Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-29 @ 1:21 PM
Study NCT ID:
NCT01233895
Status:
COMPLETED
Last Update Posted:
2010-11-03
First Post:
2010-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma
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': 'C545477', 'term': 'AVE1642'}, {'id': 'D000069286', 'term': 'Bortezomib'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-02', 'studyFirstSubmitDate': '2010-10-29', 'studyFirstSubmitQcDate': '2010-11-02', 'lastUpdatePostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'definition of the Selected Dose (SD)', 'timeFrame': '2 years', 'description': 'Selected Dose will be based on the AVE1642 clearance /IGF-1 plateaus and on safety (less than 33% of pts with dose limiting toxicity (DLT)when administered as single agent in a first part of the study. The safety and pharmacokinetics of the regimen in combination with bortezomib will be assessed in the second part of the study'}], 'secondaryOutcomes': [{'measure': 'Assess the efficacy (complete, partial, minimal responses and stabilizations)', 'timeFrame': '2 years', 'description': 'According to the European Group for Blood and Marrow Transplantation (EBMT) criteria when appropriate (e.g. baseline M Protein, % Plasma Cells in Bone Marrow,skeletal disease status and at least one evaluable post-baseline assessment)'}, {'measure': 'Pharmacokinetic drug interaction between AVE1642 and Velcade (part 2)', 'timeFrame': 'Day 22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Primary Objectives:\n\nStudy Part 1: Determine the selected dose of AVE1642 administered every 3 weeks based on pharmacokinetic (PK) (Clearance of AVE1642), pharmacodynamic (PD) (insulin-like growth factor 1 \\[IGF-1\\] serum level) parameters, and eventual dose limiting toxicities (DLTs) in patients with recurrent, refractory multiple myeloma (MM).\n\nStudy Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®.\n\nSecondary Objectives :\n\nStudy Part 1:\n\n* To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs)\n* To assess the biological activity of AVE1642 (saturation of the receptors and down-regulation) on malignant plasma cells and on peripheral blood mononuclear cells (PBMC) and granulocytes\n* To assess the biological activity of AVE1642 on the signalization pathway of the IGF-1 system (phosphorylated akt \\[pAkt\\], phosphorylated erk \\[pErk\\]) on malignant plasma cells when technically possible\n* To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3\n* To assess clinical efficacy (complete response \\[CR\\], partial response \\[PR\\], minimal response \\[MR\\] and stabilization) based on the European group for Blood and Marrow Transplantation (EBMT) criteria, when possible\n* To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642\n\nStudy Part 2:\n\n* To detect any PK or PD interaction between AVE1642 and Velcade®\n* To assess clinical efficacy (CR, PR, MR, no change \\[NC\\]) according to EBMT criteria when appropriate\n* To assess biological activity of AVE1642 in combination with Velcade® on malignant plasma cells collected from bone marrow aspirates: saturation and down-regulation of the insulin-like growth factor 1 receptor (IGF-1R) and activity on the signalization pathway of the IGF-1 system (pAkt, pErk) when feasible\n* To detect immunogenicity reaction (HAHA)\n* To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Multiple myeloma confirmed by bone marrow aspirate or biopsy\n* Patient had to have relapsed and/or refractory multiple myeloma after at least 1 standard therapy, and have demonstrated disease progression\n* Previous exposure to Velcade was allowed, provided no DLTs of Grade 3 or above had been observed during previous treatment (for Part 2 of the study only)\n\nExclusion Criteria:\n\n* Prior therapy with any IGF-1 system targeting compound\n* History of allogenic stem cell transplantation in case of concomitant immunosuppressive therapy within 6 months before study entry. Patients having undergone autologous stem cell transplantation(s) may have been included in the study\n* History of organ transplant and any patient receiving long term systemic immunosuppressive therapy\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01233895', 'briefTitle': 'Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Open Label Study of the Anti Insulin-like Growth Factor 1 Receptor (IGF-1R) Monoclonal Antibody, AVE1642, as Single Agent (Dose Escalation, Part 1) and in Combination With Velcade® (Combination, Part 2) in Patients With Recurrent, Refractory Multiple Myeloma (MM)', 'orgStudyIdInfo': {'id': 'TED6420'}, 'secondaryIdInfos': [{'id': 'AVE1642A/1001', 'type': 'OTHER', 'domain': 'other sanofi-aventis reference'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AVE1642/ AVE1642 with Velcade', 'interventionNames': ['Drug: AVE1642', 'Drug: Velcade']}], 'interventions': [{'name': 'AVE1642', 'type': 'DRUG', 'description': 'For Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg', 'armGroupLabels': ['AVE1642/ AVE1642 with Velcade']}, {'name': 'Velcade', 'type': 'DRUG', 'otherNames': ['Bortezomib'], 'description': 'For Part 2 ONLY, fixed dose of 1.3 mg/m² administered on Days 1, 4, 8, and 11.', 'armGroupLabels': ['AVE1642/ AVE1642 with Velcade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Sanofi-Aventis Investigational Site Number 250002', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Sanofi-Aventis Investigational Site Number 250001', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Sanofi-Aventis Investigational Site Number 250003', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Sanofi-Aventis Investigational Site Number 380001', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Trial Transparency Team', 'oldOrganization': 'sanofi-aventis'}}}}