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

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: docetaxel; Drug: ANX-514

• Registration Number: NCT00664170
• Lead Sponsor: Mast Therapeutics, Inc.

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

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-18
• Study First Submitted QC: 2008-04-18
• Study First Posted: 2008-04-22
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	docetaxel	Taxotere
1	ANX-514	ANX-514

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic equivalence of ANX-514 and Taxotere

Trial Locations

Locations (13)

UCSD Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Tallinn Cancer Clinic; 🇪🇪 Tallinn, Estonia

Signal Point Hematology/Oncology Inc.; 🇺🇸 Middletown, Ohio, United States

Northwest Alabama Cancer Center; 🇺🇸 Muscle Shoals, Alabama, United States

Marcelo T de Alvear; 🇦🇷 Buenos Aires, Argentina

Isis Centro Especializado; 🇦🇷 Santa Fe, Argentina

Centro Oncologico de Integracion Regional; 🇦🇷 Mendoza, Argentina

Hospital Universitario Austral; 🇦🇷 Buenos Aires, Provincia de Buenos Aires, Argentina

Hospital Privado Santa Clara de Asis; 🇦🇷 Salta, Argentina

Centro Medico San Roque; 🇦🇷 Tucuman, Argentina

Tartu University Hospital, Clinic of Hematology and Oncology; 🇪🇪 Tartu, Estonia

Centro Oncologico de Rosario; 🇦🇷 Rosario, Santa Fe, Argentina

Hospital Regional de Concepcion; 🇦🇷 Concepcion, Tucuman, Argentina