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

This study has been completed.

First Received on April 18, 2008. Last Updated on May 27, 2009 History of Changes

Sponsor:	Adventrx Pharmaceuticals
Information provided by:	Adventrx Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00664170

Purpose

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

Condition	Intervention	Phase
Advanced Cancer	Drug: ANX-514 Drug: docetaxel	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Hydroxyzine Hydroxyzine pamoate Docetaxel Hydroxyzine dihydrochloride

U.S. FDA Resources

Further study details as provided by Adventrx Pharmaceuticals:

Primary Outcome Measures:

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

Enrollment:	39
Study Start Date:	April 2008
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 ANX-514	Drug: ANX-514 75 mg/m^2 Other Name: Docetaxel for Injectable Emulsion
Active Comparator: 2 Taxotere	Drug: docetaxel 75 mg/m^2 Other Name: Taxotere

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664170

Locations

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

Sponsors and Collaborators

Adventrx Pharmaceuticals

Investigators

Study Director:

Jeff Stewart, MBA

Adventrx Pharmaceuticals

More Information

No publications provided

Responsible Party:	Michele Yelmene, Adventrx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00664170 History of Changes
Other Study ID Numbers:	ANX 514-01
Study First Received:	April 18, 2008
Last Updated:	May 27, 2009
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Estonia: Ravimiamet State Agency of Medicines

Additional relevant MeSH terms:

Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012