Status:
COMPLETED
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Lead Sponsor:
Mast Therapeutics, Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00664170
Start Date
April 1 2008
End Date
April 1 2009
Last Update
May 28 2009
Active Locations (13)
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1
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
3
Signal Point Hematology/Oncology Inc.
Middletown, Ohio, United States, 45042
4
Hospital Universitario Austral
Buenos Aires, Buenos Aires, Argentina