CLINICAL TRIALS PROFILE FOR SARCLISA
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All Clinical Trials for SARCLISA
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01084252 ↗ | Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies | Active, not recruiting | Sanofi | Phase 1/Phase 2 | 2010-06-10 | Primary Objective: Phase 1: To determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) of SAR650984 (Isatuximab). Phase 2 (stage 1): To evaluate the activity of single-agent Isatuximab at different doses/schedules and to select dose and regimen to further evaluate the overall response rate (ORR) of Isatuximab as single agent or in combination with dexamethasone. Phase 2 (stage 2): To evaluate the activity in terms of overall response rate (ORR) of Isatuximab at the selected dose/schedule from stage1, as single agent (ISA arm) and in combination with dexamethasone (ISAdex arm). Secondary Objectives: Phase 1: - To characterize the global safety profile including cumulative toxicities. - To evaluate the pharmacokinetic (PK) profile of Isatuximab in the proposed dosing schedule(s). - To assess the pharmacodynamics (PD), immune response, and preliminary disease response. Phase 2 (stage 1): to evaluate the following objectives for Isatuximab as single agent: - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. Phase 2 (stage 2): to evaluate the following objectives in each arm (ISA and ISAdex): - Safety - Efficacy as measured by duration of response, clinical benefit rate, progression free survival, overall survival. - Participant-reported changes in health-related quality of life, symptoms of multiple myeloma and generic health status. - Pharmacokinetic profile of Isatuximab. - Immunogenicity of Isatuximab. - Investigate the relationship between CD38 receptor density and CD38 receptor occupancy (Stage 1 only) on multiple myeloma cells and parameters of clinical response. |
| NCT01749969 ↗ | SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients | Active, not recruiting | Sanofi | Phase 1 | 2013-02-06 | Primary Objectives: - To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma. - Expansion Phase Only: To further evaluate preliminary evidence of antitumor activity (objective response rate [ORR]) of SAR650984 (isatuximab) in combination with LD using International Myeloma Working Group (IMWG) criteria. Secondary Objectives: - To evaluate the safety, including immunogenicity, of SAR650984 (isatuximab) in combination with LD in relapsed or refractory multiple myeloma. The severity, frequency and incidence of all toxicities will be assessed. - To evaluate the pharmacokinetics (PK) of SAR650984 (isatuximab) when administered in combination with LD and the PK of lenalidomide in combination with SAR650984 and dexamethasone. - To assess the relationship between clinical (adverse event [AE] and/or tumor response) effects and pharmacologic parameters (PK/pharmacodynamics), and/or biologic (correlative laboratory) results. - For the dose expansion phase, estimate the activity (ORR) using IMWG defined response criteria of SAR650984 (isatuximab) plus LD. - To describe progression-free survival (PFS) in patients treated with this combination. |
| NCT02283775 ↗ | SAR650984, Pomalidomide and Dexamethasone in Combination in RRMM Patients | Completed | Sanofi | Phase 1 | 2015-05-15 | Primary Objectives: Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple Myeloma (RRMM). Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions (IAR). Secondary Objectives: - To evaluate the infusion duration (Part B). - To evaluate the safety profile of the combination with isatuximab administration from fixed volume (Part B). - To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B). - To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of pomalidomide when administered in combination (Part A). - To describe the efficacy of the combination of SAR650984 with Pd in terms of overall response rate and clinical benefit rate based on International Myeloma Working Group (IMWG) defined response criteria and the duration of response (Part A and B). - To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density at baseline (Part A). |
| NCT02513186 ↗ | Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation | Active, not recruiting | Sanofi | Phase 1 | 2015-09-30 | Primary Objectives: - VCDI cohort: - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation - To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria. - VRDI Part A cohort and Part B cohort: - To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation. Secondary Objectives: - VCDI cohort: - To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities. - To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen. - To evaluate the immunogenicity of SAR650984 in combination treatments. - To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival. - To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density. - VRDI Part A cohort and Part B cohort: - To characterize the overall safety profile of isatuximab in combination with VRD regimen. - To evaluate the infusion duration (only applicable for VRDI Part B cohort) - To characterize the PK profile of isatuximab and each combination drug in VRDI regimen. - To evaluate the immunogenicity of isatuximab in combination treatments. - To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS. - To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment. - To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort). - To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome. |
| NCT02514668 ↗ | A Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Isatuximab in Patients With Multiple Myeloma | Active, not recruiting | Sanofi | Phase 1 | 2015-09-01 | Primary Objective: - Part A: To evaluate the safety of SAR650984 (isatuximab) in patients with relapsed/refractory multiple myeloma (RRMM). - Part B: To evaluate the activity of SAR650984 (isatuximab) as assessed by overall response rate (ORR) in RRMM patients previously treated with daratumumab. Secondary Objectives: - Part A: - To determine the pharmacokinetics (PK) of SAR650984 (isatuximab) in patients with RRMM. - Part B: - To evaluate the safety of SAR650984 (isatuximab). - To evaluate the efficacy of SAR650984 (isatuximab) as assessed by duration of response (DOR), clinical benefit rate (CBR) and progression free survival (PFS). - To assess the pharmacokinetics (PK) of SAR650984 (isatuximab) and daratumumab at baseline. - To evaluate the immunogenicity of SAR650984 (isatuximab). |
| NCT02812706 ↗ | Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients | Active, not recruiting | Sanofi | Phase 1/Phase 2 | 2016-09-05 | Primary Objectives: - Phase I: To evaluate safety and tolerability of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. - Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese patients with relapsed and refractory multiple myeloma. Secondary Objectives: - To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events will be assessed. - To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. - To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. - To assess the relationship between baseline CD38 receptor density on multiple myeloma cells and efficacy. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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