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



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:April 2008
End Date:April 2009

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


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.
We found this trial at
4
sites
Buenos Aires, Provincia de Buenos Aires
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Buenos Aires,
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La Jolla, California 92093
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La Jolla, CA
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Middletown, Ohio 45042
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Middletown, OH
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Muscle Shoals, Alabama 35661
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Muscle Shoals, AL
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