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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetic equivalence of ANX-514 and Taxotere

Safety Issue:

No

Principal Investigator

Jeff Stewart, MBA

Investigator Role:

Study Director

Investigator Affiliation:

Mast Therapeutics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

ANX 514-01

NCT ID:

NCT00664170

Start Date:

April 2008

Completion Date:

April 2009

Related Keywords:

  • Advanced Cancer
  • Neoplasms

Name

Location

UCSD Moores Cancer CenterLa Jolla, California  93093
Northwest Alabama Cancer CenterMuscle Shoals, Alabama  35661
Signal Point Hematology/Oncology Inc.Middletown, Ohio  45042