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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mast Therapeutics, Inc.
• Treatments: Docetaxel

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.