Skip to main content
OpenTrials
Completed

NCT Number: NCT00664170

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

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Universitario Austral, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ANX-514

Drug

75 mg/m^2

Other names: Docetaxel for Injectable Emulsion

docetaxel

Drug

75 mg/m^2

Other names: Taxotere

Primary outcomes

  1. Pharmacokinetic equivalence of ANX-514 and Taxotere

Sponsors and collaborators

Lead sponsor

Mast Therapeutics, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.