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

Completed · Phase 1

Conditions studied: Advanced Cancer

In brief

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

Key facts

Study ID

NCT00664170

Run by

Mast Therapeutics, Inc.

People needed

39

Starts

2008-04-01

Expected to finish

2009-04-01

Last updated by the study team

2009-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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