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

January 19, 2012 updated by: Mast Therapeutics, Inc.

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

ANX-530 (vinorelbine tartrate injectable emulsion), an investigational drug, is an oil-in-water emulsion of vinorelbine tartrate composed of an oil phase and emulsifier dispersed in an aqueous solution. ADVENTRX Pharmaceuticals, Inc. of San Diego, California, developed ANX-530 as a vinorelbine tartrate formulation to be used in clinical settings where Vinorelbine Tartrate Injection (NAVELBINE) is indicated. Nonclinical toxicology studies suggest either equivalent or less toxicity of ANX-530 compared to Reference Product. In particular, ANX-530 caused less vein toxicity in a rabbit vein irritation model, suggesting ANX-530 could potentially cause less venous irritation than NAVELBINE in a clinical setting. ADVENTRX is investigating whether ANX-530 could substitute for NAVELBINE in these settings.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Clinical Investigative Site
      • Mendoza, Argentina
        • Clinical Investigative Site
      • Rosario, Argentina
        • Clinical Investigative Site
      • Santa Fe, Argentina
        • Clinical Investigative Site
      • Tucuman, Argentina
        • Clinical Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years.
  • Advanced cancer potentially sensitive to vinorelbine:
  • Breast cancer.
  • Stage 3 or 4 non-small cell lung cancer.
  • Non-Hodgkins lymphoma.
  • Cancer of other histologic type, sensitive to vinca alkaloids.
  • Rare tumor type with no standard treatment, for which single agent vinorelbine is appropriate therapy.
  • Failure of standard treatment(s) of the tumor.
  • Life expectancy of at least three months.
  • ECOG performance level 0-2 or Karnofsky score 100-70.
  • Hematological and serum chemistry results with defined ranges.
  • Willingness and ability to provide written informed consent.

Exclusion Criteria:

  • Pregnancy or lactation. In a woman of childbearing potential, a positive pregnancy test result, no pregnancy test result, or no use of reliable contraception, at baseline. A postmenopausal woman will be considered to be of childbearing potential until there has been amenorrhea for at least 12 consecutive months.
  • Previous treatment with vinorelbine or mitomycin.
  • Any history suggesting or demonstrating resistance to, lack of response to, or intolerance of any prior vinca alkaloid treatment.
  • Active infection.
  • Prior anticancer therapy completed within four weeks prior to the first day of study treatment.
  • Failure to have recovered from any toxicity of previous cancer treatment (patients with alopecia will not be excluded).
  • Participation in another experimental drug study within four weeks prior to the first day of study treatment.
  • Requirement for any concomitant chemotherapeutic agent other than the study medication.
  • Any investigator judgment that the individual would not be an appropriate study subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 0-144 hours post dose
0-144 hours post dose
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0-144 hours post-dose
0-144 hours post-dose
Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time Frame: 0-144 hours post-dose
Determined Using the Linear Trapezoidal Rule
0-144 hours post-dose
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
Time Frame: 0-144 hours post-dose
AUCinf = AUClast + (Clast/lamda z)
0-144 hours post-dose
Percentage of AUCinf Based on Extrapolation (AUCextrap)
Time Frame: 0-144 hours post-dose
0-144 hours post-dose
Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
Time Frame: 0-144 hours post-dose
Estimated via linear regression of the time versus log concentration
0-144 hours post-dose
Observed Terminal Elimination Half-Life (t1/2)
Time Frame: 0-144 hours post-dose
t1/2 = [ln(2)/λ z]
0-144 hours post-dose
Time of Last Measurable Concentration (Tlast)
Time Frame: 0-144 hours post-dose
0-144 hours post-dose
Last Quantifiable Drug Concentration (Clast)
Time Frame: 0-144 hours post-dose
0-144 hours post-dose
Mean Residence Time (MRTinf)
Time Frame: 0-144 hours post-dose
MRT = (AUMCinf)/(AUCinf)
0-144 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mast Therapeutics, Inc.

Collaborators

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

Investigators

  • Principal Investigator: Lino Arboit, M.D., Fundación Centro Oncológico de Integración Regional - COIR.
  • Principal Investigator: Gerardo F Arroyo, M.D., Hospital Privado De Santa Clara De Asis
  • Principal Investigator: Cesar R Blajman, M.D., ISIS Clinica Especializada
  • Principal Investigator: Matias Chacon, M.D., Instituto Médico Espcializado Alexander Fleming
  • Principal Investigator: Luis E Fein, M.D., Centro Oncologico
  • Principal Investigator: Hugo R. Requejo, M.D., Hospital Regional de Concepcion
  • Principal Investigator: Edgar P Quintana, M.D., CIMA Salud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ACTUAL)

November 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

February 6, 2007

First Submitted That Met QC Criteria

February 6, 2007

First Posted (ESTIMATE)

February 8, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

February 23, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 530-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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