Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

CompletadoFase 3ClinicalTrials.gov

ID: NCT00974311Tipo: INTERVENTIONALInicio: 30 de sept de 2009Fin estimado: 2 de nov de 2017

Traducción no disponible, mostrando original

Resumen

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Elegibilidad

Edad mínima: 18 YearsSexo: MALE

Criterios de inclusión

Progressive prostate cancer
Medical or surgical castration with testosterone less than 50 ng/dl
One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow, hepatic, and renal function
Able to swallow the study drug and comply with study requirements
Informed consent

Criterios de exclusión

Metastases in the brain or active epidural disease
Another malignancy within the previous 5 years
Clinically significant cardiovascular disease
Gastrointestinal disorder affecting absorption

Intervenciones

drug

Enzalutamide

MDV3100, 160 mg orally per day

drug

Placebo

Placebo comparator

Ubicaciones

Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)

Buenos Aires, AR, Argentina

Instituto Oulton

Córdoba, Córdoba Province, Argentina

Clinica Universitaria Privada Reina Fabiola

Córdoba, Córdoba Province, Argentina

Policlinico Neuquen

Neuquén, Neuquén Province, Argentina

Policlinico Modelo de Cipolletti

Cipolletti, Río Negro Province, Argentina

Instituto de Investigaciones Clinicas Cipolletti

Cipolletti, Río Negro Province, Argentina

Sanatorio Mapaci

Rosario, Santa Fe Province, Argentina

Instituto de Oncologia y Especialidades Medicas

Rosario, Santa Fe Province, Argentina

Hospital Italiano Garibaldi

Rosario, Santa Fe Province, Argentina

Centro de Diagnostico Dr. Enrique Rossi

Buenos Aires, Argentina

Centro de Diagnostico Dr. Enrique Rossi

Buenos Aires, Argentina

Patrocinadores

PrincipalPfizer

ColaboradorAstellas Pharma Inc

ColaboradorMedivation LLC, a wholly owned subsidiary of Pfizer Inc.

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