A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

TerminadoFase 3ClinicalTrials.gov

ID: NCT00849667Tipo: INTERVENTIONALInicio: 16 de abr de 2009Fin estimado: 12 de abr de 2013

Traducción no disponible, mostrando original

Resumen

This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
Must have measurable disease by CT or MRI scan
Must have relapsed radiologically with a randomization date within ≥6 and \< 24 months of completion of first-line platinum chemotherapy
Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
Must be a candidate for carboplatin and taxane therapy
Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Criterios de exclusión

Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs \<6 months or \>24 months from the last platinum therapy
Subjects who have received other therapy to treat their ovarian cancer since relapse
Known central nervous system (CNS) tumor involvement
Evidence of other active invasive malignancy requiring treatment in the past 5 years
Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
Previous treatment with MORAb-003 (farletuzumab)
Clinical contraindications to use of a taxane

Intervenciones

drug

Farletuzumab

Farletuzumab IV infusion.

drug

Carboplatin

Carboplatin IV infusion.

drug

Taxane

Taxane (Paclitaxel or Docetaxel) IV infusion.

drug

Farletuzumab-matched placebo

Farletuzumab-matched placebo IV infusion.

Ubicaciones

Hospital Zonal Especializado en Oncología de Lanús

Buenos Aires, Argentina

Consultorios Medicos Privados SA

Buenos Aries, Argentina

Fundación Sanatorio Güemes

CABA, Argentina

Clinica Universitaria Reina Fabiola

Códoba, Argentina

Instituto Medico Platense

La Plata, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Hospital Bocalandro

Loma Hermosa, Argentina

Centro Oncologico Integral

Mar del Plata, Argentina

CER Instituto Medico

Quilmes, Argentina

Centro Médico San Roque

San Miguel de Tucumán, Argentina

Centro Medico de Alta Complejidad Cemac

San Salvador de Jujuy, Argentina

ISIS Centro Especializado de LUCE SA

Santa Fe, Argentina

Patrocinadores

PrincipalMorphotek

ColaboradorEisai Europe Ltd. (United Kingdom)

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