A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

CompletadoFase 1ClinicalTrials.gov

ID: NCT00664170Tipo: INTERVENTIONALInicio: 1 de abr de 2008Fin estimado: 1 de abr de 2009

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Over 18 years old.
Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
ECOG performance status of 0-2 and Karnofsky Score of 100-70.

Criterios de exclusión

Pregnancy or lactation.
Patients who have more effective therapy available than single agent docetaxel for the malignancy.
Intolerance to any antineoplastic agents belonging to the taxoid family.
Hypersensitivity to drugs formulated with polysorbate 80.
Active infection.
Prior anticancer therapy within 30 days prior to the first day of study treatment.
Participation in another experimental drug study within 30 days prior to the first day of study treatment.

Intervenciones

drug

ANX-514

75 mg/m\^2

drug

docetaxel

75 mg/m\^2

Ubicaciones

Hospital Universitario Austral

Buenos Aires, Buenos Aires, Argentina

Centro Oncologico de Rosario

Rosario, Santa Fe Province, Argentina

Hospital Regional de Concepcion

Concepción, Tucumán Province, Argentina

Marcelo T de Alvear

Buenos Aires, Argentina

Centro Oncologico de Integracion Regional

Mendoza, Argentina

Hospital Privado Santa Clara de Asis

Salta, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Argentina

Isis Centro Especializado

Santa Fe, Argentina

Patrocinadores

PrincipalMast Therapeutics, Inc.

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