MedTrace Logo

A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion in Patients With Advanced Cancer.

NCT00432562 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-02-23

Study results available
· View outcomes & findings →

Summary

This study was a randomized, single dose crossover comparison of the investigational product with a Reference Product (vinorelbine tartrate injection, NAVELBINE®). The primary objective was to demonstrate the equivalence of ANX-530 and the Reference Product, NAVELBINE.

Conditions

Interventions

DRUG

Vinorelbine Tartrate

Subjects received one dose each of ANX-530 and NAVELBINE, each providing 30 mg/m2 vinorelbine. Study drugs will be infused into an arm vein over ten minutes.

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Thywill Latam Solutions SRL

    collaborator UNKNOWN

  • OCASA Soluciones Logísticas S.A.

    collaborator UNKNOWN

  • Worldwide Clinical Trials

    collaborator OTHER

  • Mast Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Lino Arboit, M.D. · Fundación Centro Oncológico de Integración Regional - COIR.

  • Gerardo F Arroyo, M.D. · Hospital Privado De Santa Clara De Asis

  • Cesar R Blajman, M.D. · Isis Clínica Especializada

  • Matias Chacon, M.D. · Instituto Médico Espcializado Alexander Fleming

  • Luis E Fein, M.D. · Centro Oncológico

  • Hugo R. Requejo, M.D. · Hospital Regional De Concepción

  • Edgar P Quintana, M.D. · CIMA Salud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2007-11-30
Completion
2007-12-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00432562 on ClinicalTrials.gov