Calendario›SNY›AVE1642
AVE1642
Study of AVE1642 Anti-IGF1R Monoclonal Antibody in Patients With Advanced Multiple Myeloma
Ensayo de Sanofi en Mieloma multiple.
Más ensayos de: Mieloma múltiple.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 26
- Centros
- 4
- Fin del objetivo primario
- sep 2008
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en sep 2006.
Qué mide
definition of the Selected Dose (SD) (del registro, en inglés) (2 años)
Cómo lo describe el promotor
En el documentoEn inglés, del registroPrimary Objectives: Study 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). Study Part 2: Assess the safety of the combination of the selected dose of AVE1642 with the recommended dose of Velcade®. Secondary Objectives : Study Part 1: * To assess the safety profile: type, incidence and intensity of drug related adverse events (AEs) * 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 * 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 * To define PK profile of AVE1642, and its PD effects on serum IGF 1, GF 2 and IGFBP-3 * 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 * To assess potential immunogenicity by detection of human antihumanized antibodies (HAHA) anti-AVE1642 Study Part 2: * To detect any PK or PD interaction between AVE1642 and Velcade® * To assess clinical efficacy (CR, PR, MR, no change \[NC\]) according to EBMT criteria when appropriate * 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 * To detect immunogenicity reaction (HAHA) * To characterize PK and PD profile of a low dose (0.5 mg/kg) of AVE1642 expected to be non biologically active
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Ficha completa en ClinicalTrials.gov (NCT01233895), actualizada en nov 2010.