A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
1 other identifier
interventional
39
3 countries
13
Brief Summary
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2008
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMay 28, 2009
May 1, 2009
1 year
April 18, 2008
May 27, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic equivalence of ANX-514 and Taxotere
Study Arms (2)
1
EXPERIMENTALANX-514
2
ACTIVE COMPARATORTaxotere
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Northwest Alabama Cancer Center
Muscle Shoals, Alabama, 35661, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
Signal Point Hematology/Oncology Inc.
Middletown, Ohio, 45042, United States
Hospital Universitario Austral
Buenos Aires, Buenos Aires, Argentina
Centro Oncologico de Rosario
Rosario, Santa Fe Province, CP 2000, Argentina
Hospital Regional de Concepcion
Concepción, Tucumán Province, 4146, Argentina
Marcelo T de Alvear
Buenos Aires, 1122, Argentina
Centro Oncologico de Integracion Regional
Mendoza, 5500, Argentina
Hospital Privado Santa Clara de Asis
Salta, 4400, Argentina
Centro Medico San Roque
San Miguel de Tucumán, 4000, Argentina
Isis Centro Especializado
Santa Fe, S3000FFU, Argentina
Tallinn Cancer Clinic
Tallinn, 10167, Estonia
Tartu University Hospital, Clinic of Hematology and Oncology
Tartu, 51003, Estonia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeff Stewart, MBA
Mast Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 18, 2008
First Posted
April 22, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
May 28, 2009
Record last verified: 2009-05