A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
NCT ID: NCT00664170
Last Updated: 2009-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2008-04-30
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
ANX-514
ANX-514
75 mg/m\^2
2
Taxotere
docetaxel
75 mg/m\^2
Interventions
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ANX-514
75 mg/m\^2
docetaxel
75 mg/m\^2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mast Therapeutics, Inc.
INDUSTRY
Responsible Party
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Adventrx Pharmaceuticals, Inc.
Principal Investigators
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Jeff Stewart, MBA
Role: STUDY_DIRECTOR
Mast Therapeutics, Inc.
Locations
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Northwest Alabama Cancer Center
Muscle Shoals, Alabama, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Signal Point Hematology/Oncology Inc.
Middletown, Ohio, United States
Hospital Universitario Austral
Buenos Aires, Buenos Aires, Argentina
Centro Oncologico de Rosario
Rosario, Santa Fe Province, Argentina
Hospital Regional de Concepcion
Concepción, Tucumán Province, Argentina
Marcelo T de Alvear
Buenos Aires, , Argentina
Centro Oncologico de Integracion Regional
Mendoza, , Argentina
Hospital Privado Santa Clara de Asis
Salta, , Argentina
Centro Medico San Roque
San Miguel de Tucumán, , Argentina
Isis Centro Especializado
Santa Fe, , Argentina
Tallinn Cancer Clinic
Tallinn, , Estonia
Tartu University Hospital, Clinic of Hematology and Oncology
Tartu, , Estonia
Countries
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Other Identifiers
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ANX 514-01
Identifier Type: -
Identifier Source: org_study_id