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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00664170
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : May 28, 2009
Information provided by:
Mast Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: ANX-514 Drug: docetaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Study Start Date : April 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: 1
Drug: ANX-514
75 mg/m^2
Other Name: Docetaxel for Injectable Emulsion

Active Comparator: 2
Drug: docetaxel
75 mg/m^2
Other Name: Taxotere

Primary Outcome Measures :
  1. Pharmacokinetic equivalence of ANX-514 and Taxotere

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00664170

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United States, Alabama
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States, 35661
United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
United States, Ohio
Signal Point Hematology/Oncology Inc.
Middletown, Ohio, United States, 45042
Hospital Universitario Austral
Buenos Aires, Provincia de Buenos Aires, Argentina
Centro Oncologico de Rosario
Rosario, Santa Fe, Argentina, CP 2000
Hospital Regional de Concepcion
Concepcion, Tucuman, Argentina, 4146
Marcelo T de Alvear
Buenos Aires, Argentina, 1122
Centro Oncologico de Integracion Regional
Mendoza, Argentina, 5500
Hospital Privado Santa Clara de Asis
Salta, Argentina, 4400
Isis Centro Especializado
Santa Fe, Argentina, S3000FFU
Centro Medico San Roque
Tucuman, Argentina, 4000
Tallinn Cancer Clinic
Tallinn, Estonia, 10167
Tartu University Hospital, Clinic of Hematology and Oncology
Tartu, Estonia, 51003
Sponsors and Collaborators
Mast Therapeutics, Inc.
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Study Director: Jeff Stewart, MBA Mast Therapeutics, Inc.
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Responsible Party: Michele Yelmene, Adventrx Pharmaceuticals, Inc. Identifier: NCT00664170    
Other Study ID Numbers: ANX 514-01
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009
Additional relevant MeSH terms:
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Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action