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

May 27, 2009 updated by: Mast Therapeutics, Inc.
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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, 1122
        • Marcelo T de Alvear
      • Mendoza, Argentina, 5500
        • Centro Oncologico de Integracion Regional
      • Salta, Argentina, 4400
        • Hospital Privado Santa Clara de Asis
      • Santa Fe, Argentina, S3000FFU
        • ISIS Centro especializado
      • Tucuman, Argentina, 4000
        • Centro Medico San Roque
    • Provincia de Buenos Aires
      • Buenos Aires, Provincia de Buenos Aires, Argentina
        • Hospital Universitario Austral
    • Santa Fe
      • Rosario, Santa Fe, Argentina, CP 2000
        • Centro Oncologico de Rosario
    • Tucuman
      • Concepcion, Tucuman, Argentina, 4146
        • Hospital Regional de Concepción
  • Estonia
      • Tallinn, Estonia, 10167
        • Tallinn Cancer Clinic
      • Tartu, Estonia, 51003
        • Tartu University Hospital, Clinic of Hematology and Oncology
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Northwest Alabama Cancer Center
    • California
      • La Jolla, California, United States, 92093
        • UCSD Moores Cancer Center
    • Ohio
      • Middletown, Ohio, United States, 45042
        • Signal Point Hematology/Oncology Inc.

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:

  • 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.

Exclusion Criteria:

  • Patients who have more effective therapy available than single agent docetaxel for the malignancy.
  • Pregnancy or lactation.
  • 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.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ANX-514
Drug: ANX-514
75 mg/m^2
Other Names:
  • Docetaxel for Injectable Emulsion
Active Comparator: 2
Taxotere
Drug: docetaxel
75 mg/m^2
Other Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetic equivalence of ANX-514 and Taxotere

Collaborators and Investigators

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

Sponsor

Mast Therapeutics, Inc.

Investigators

  • Study Director: Jeff Stewart, MBA, Mast Therapeutics, Inc.

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

April 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2009

Last Update Submitted That Met QC Criteria

May 27, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANX 514-01

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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