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

Tracking Information

First Received Date ^ICMJE

April 18, 2008

Last Updated Date

May 27, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic equivalence of ANX-514 and Taxotere [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00664170 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Condition ^ICMJE

Advanced Cancer

Intervention ^ICMJE

Drug: ANX-514
Drug: docetaxel

Study Arms / Comparison Groups

Experimental: ANX-514
Active Comparator: Taxotere

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Estonia

Administrative Information

NCT ID ^ICMJE

NCT00664170

Responsible Party

Michele Yelmene, Adventrx Pharmaceuticals, Inc.

Study ID Numbers ^ICMJE

ANX 514-01

Study Sponsor ^ICMJE

Adventrx Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jeff Stewart, MBA

Adventrx Pharmaceuticals

Information Provided By

Adventrx Pharmaceuticals

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP