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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- 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
Outcome Measures for this Clinical Trial
Primary Measures
- Pharmacokinetic equivalence of ANX-514 and Taxotere
- Safety Issue?: No
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Adventrx Pharmaceuticals Industry
Overall Clinical Trial Officials and Contacts
Jeff Stewart, MBA Study Director Adventrx Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00664170
