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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: April 2009

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ANX-514
• Active Comparator: 2
  • Taxotere

Primary Measures

• Pharmacokinetic equivalence of ANX-514 and Taxotere
  • Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Adventrx Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Jeff Stewart, MBA Study Director Adventrx Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664170

Study ID Number: ANX 514-01

ClinicalTrials.gov Identifier: NCT00664170

Health Authority: United States: Food and Drug Administration