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AMG 951

A Study of AMG 951 [rhApo2L/TRAIL] in Subjects With Previously Untreated Non-Small Cell Lung Cancer (NSCLC) Treated With Chemotherapy +/- Bevacizumab

Ensayo de AMGEN INC en Cancer de pulmon no microcitico.

Más ensayos de: Cáncer de pulmón no microcítico.

Fase

Fase 2

Estado

Completado

Participantes

213

previstos

Fin del objetivo primario

mar 2009

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en jun 2006.

Qué mide

Objective response rate (CR and PR) by modified RECIST (Until disease progression, drug intolerability or withdrawal of consent) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a phase 2 multicenter, open label, randomized study of AMG 951 (rhApo2L/TRAIL) in subjects with previously untreated stage IIIb/IV NSCLC treated with chemotherapy with or without bevacizumab. Subjects will be assigned to a set of treatment groups depending on their eligibility to receive bevacizumab. Subjects with squamous NSCLC and/or CNS metastases will not be eligible to receive bevacizumab and will be assigned to either cohort A or B (provided all other eligibility criteria are met). Subjects who are eligible to receive bevacizumab will be assigned to cohort C, D or E. Cohorts are defined as follows: Subjects with squamous NSCLC or CNS mets: Cohort A: Chemotherapy alone Cohort B: Chemotherapy plus 8 mg/kg AMG 951 for 5 days Subjects without squamous NSCLC and without CNS mets: Cohort C: Chemotherapy and bevacizumab Cohort D: Chemotherapy, bevacizumab plus 8 mg/kg AMG 951 for 5 days Cohort E: Chemotherapy, bevacizumab plus up to 20 mg/kg AMG 951 for 2 days Approximately forty subjects will be recruited to each cohort.

Más ensayos de AMGN

Todos los de AMGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00508625), actualizada en jun 2016.