Calendario›SNY›Xaliproden

Xaliproden

Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

Ensayo de Sanofi en Metastases · Colorectal Neoplasms · Colorectal Carcinoma (del registro, en inglés).

Más ensayos de: Cáncer colorrectal.

Fase

Fase 3

Estado

Completado

Participantes

879

previstos

Centros

13

Fin del objetivo primario

oct 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en dic 2005.

Qué mide

Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment (Q2W during treatment, Q4W to Q12W during post-treatment follow-up) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective : Compare the risk of occurrence of Grade3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin between treatment group and placebo group. Main Secondary Objective : Compare the response rate (RR) between treatment group and placebo group in order to ensure that the efficacy of the chemotherapy is not compromised by the addition of xaliproden to the chemotherapeutic regimen. Other Secondary Objectives : study of the neurotoxicity parameters (Duration of oxaliplatin-induced PSN (G2,3,4); overall incidence of PSN during treatment; dose of onset of PSN ; incidence of dose-reduction and dose delay due to PSN; incidence of oxaliplatin treatment discontinuation due to PSN; change in Nerve Conduction Studies (NCS)) ; study of the safety profile (other than PSN) ; study of the chemotherapy efficacy (progression free survival, overall survival).

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00305188), actualizada en abr 2016.