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

Mast Therapeutics

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer

Treatments: Drug: docetaxel; Drug: ANX-514

Study type: Interventional

Funder types: Industry

Identifiers

NCT00664170

ANX 514-01

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

1

Experimental group

Description:

ANX-514

Treatment:

Drug: ANX-514

2

Active Comparator group

Description:

Taxotere

Treatment:

Drug: docetaxel