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NCT00664170 Clinical Trial

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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00664170
Other study ID # ANX 514-01
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2008
Last updated May 27, 2009
Start date April 2008
Est. completion date April 2009

Study information
Verified date May 2009
Source Mast Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ANX-514
75 mg/m^2
• docetaxel
75 mg/m^2

Locations
Country Name City State
Argentina Hospital Universitario Austral Buenos Aires Provincia de Buenos Aires
Argentina Marcelo T de Alvear Buenos Aires
Argentina Hospital Regional de Concepcion Concepcion Tucuman
Argentina Centro Oncologico de Integracion Regional Mendoza
Argentina Centro Oncologico de Rosario Rosario Santa Fe
Argentina Hospital Privado Santa Clara de Asis Salta
Argentina Isis Centro Especializado Santa Fe
Argentina Centro Medico San Roque Tucuman
Estonia Tallinn Cancer Clinic Tallinn
Estonia Tartu University Hospital, Clinic of Hematology and Oncology Tartu
United States UCSD Moores Cancer Center La Jolla California
United States Signal Point Hematology/Oncology Inc. Middletown Ohio
United States Northwest Alabama Cancer Center Muscle Shoals Alabama

Sponsors (1)
Lead Sponsor Collaborator
Mast Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Estonia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic equivalence of ANX-514 and Taxotere
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