At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 31 enrolled

Drug / intervention

Vinorelbine Tartratedrug

Likely dose

Vinorelbine Tartrate 30 mg/m2from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00432562

NCT00432562Phase 1Completed

Compare CT.gov

A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer.

Mast Therapeutics, Inc.·interventional·Posted Feb 8, 2007·Updated Feb 23, 2012

In Brief

A Phase 1 clinical trial evaluating Vinorelbine Tartrate for Breast Cancer and 2 related conditions. Completed, enrolled 31 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer, Non-small Cell Lung Cancer, Non-Hodgkins Lymphoma

CountriesArgentina

CollaboratorsSynteract, Inc., Thywill Latam Solutions SRL, OCASA Soluciones Logísticas S.A., Worldwide Clinical Trials

Timeline

Phase 1CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2007

First PostedFeb 2007

Primary CompletionNov 2007

Study CompletionDec 2007

TodayJul 2026

First PostedFeb 8, 2007

Enrollment StartFeb 1, 2007

Primary CompletionNov 1, 2007

Study CompletionDec 1, 2007

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 19.4 years ago

Interventions

Vinorelbine Tartratedrug

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.