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 |
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere
in patients with advanced cancer.
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.
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4
sites
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