Calendario›SNY›Isatuximab SAR650984
Isatuximab SAR650984
Phase 1/2 Dose Escalation and Efficacy Study of Anti-CD38 Monoclonal Antibody in Patients With Selected CD38+ Hematological Malignancies
Ensayo de Sanofi en Hematological Malignancy (del registro, en inglés).
- Fase
- Fase 1/2
- Estado
- Completado
- Participantes
- 351
- Centros
- 59
- Fin del objetivo primario
- dic 2018
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en may 2010.
Qué mide
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) (Day 1 of Cycle 1 up to Day 14 of Cycle 2) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT01084252), actualizada en oct 2024.