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

This study has been completed.
Sponsor:
Information provided by:
Mast Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00664170
First received: April 18, 2008
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Advanced Cancer
Drug: ANX-514
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Mast Therapeutics, Inc.:

Primary Outcome Measures:
  • Pharmacokinetic equivalence of ANX-514 and Taxotere [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: April 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ANX-514
Drug: ANX-514
75 mg/m^2
Other Name: Docetaxel for Injectable Emulsion
Active Comparator: 2
Taxotere
Drug: docetaxel
75 mg/m^2
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664170

Locations
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
Argentina
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
Estonia
Tallinn Cancer Clinic
Tallinn, Estonia, 10167
Tartu University Hospital, Clinic of Hematology and Oncology
Tartu, Estonia, 51003
Sponsors and Collaborators
Mast Therapeutics, Inc.
Investigators
Study Director: Jeff Stewart, MBA Mast Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Michele Yelmene, Adventrx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00664170     History of Changes
Other Study ID Numbers: ANX 514-01
Study First Received: April 18, 2008
Last Updated: May 27, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Estonia: Ravimiamet State Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014