Calendario›SNY›AVE1642
AVE1642
Study of AVE1642 (IGF-1R/CD221) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Patients With Advanced Hormono-dependent Breast Cancer
Ensayo de Sanofi en Cancer de mama.
Más ensayos de: Cáncer de mama.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 18
- Centros
- 3
- Fin del objetivo primario
- nov 2010
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en oct 2008.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Company decision to discontinue the AVE1642 development program, not due to any safety or efficacy concerns».
Qué mide
Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles) (del registro, en inglés) (6 ciclos)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe purpose of this study is to evaluate the clinical activity of AVE1642 in combination with fulvestrant and of fulvestrant alone in terms of clinical benefit as the rate of "complete response", "partial response" and "stabilization of the disease". The additional objectives are to evaluate the safety profile of AVE1642 in combination with fulvestrant and of fulvestrant alone, to assess the rate of patients without disease progression at 6 months and the overall progression-free survival time. An evaluation of the pharmacokinetics and pharmacodynamics interactions between AVE1642 and fulvestrant will also be performed. The biological activity of treatment will be assessed on tumor biopsies, when possible The potential immunogenicity of AVE1642 will be studied
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Ficha completa en ClinicalTrials.gov (NCT00774878), actualizada en mar 2011.