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

Sponsor
Mast Therapeutics, Inc.
Study ID
NCT00432562
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine Tartrate — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 28, 2007
Status verified
Jan 2012
Primary completion
Nov 30, 2007
Completion
Dec 31, 2007

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Primary Outcome Measure

Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0-144 hours post dose ]

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