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Sponsored by: |
Adventrx Pharmaceuticals |
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Information provided by: | Adventrx Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00664170 |
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 I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer |
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 |
---|---|
1: Experimental
ANX-514
|
Drug: ANX-514
75 mg/m^2
|
2: Active Comparator
Taxotere
|
Drug: docetaxel
75 mg/m^2
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Isis Centro Especializado | |
Santa Fe, Argentina, S3000FFU | |
Hospital Privado Santa Clara de Asis | |
Salta, Argentina, 4400 | |
Centro Oncologico de Integracion Regional | |
Mendoza, Argentina, 5500 | |
Centro Medico San Roque | |
Tucuman, Argentina, 4000 | |
Marcelo T de Alvear | |
Buenos Aires, Argentina, 1122 | |
Argentina, Provincia de Buenos Aires | |
Hospital Universitario Austral | |
Buenos Aires, Provincia de Buenos Aires, Argentina | |
Argentina, Santa Fe | |
Centro Oncologico de Rosario | |
Rosario, Santa Fe, Argentina, CP 2000 | |
Argentina, Tucuman | |
Hospital Regional de Concepcion | |
Concepcion, Tucuman, Argentina, 4146 | |
Estonia | |
Tartu University Hospital, Clinic of Hematology and Oncology | |
Tartu, Estonia, 51003 | |
Tallinn Cancer Clinic | |
Tallinn, Estonia, 10167 |
Study Director: | Jeff Stewart, MBA | Adventrx Pharmaceuticals |
Responsible Party: | Adventrx Pharmaceuticals, Inc. ( Michele Yelmene ) |
Study ID Numbers: | ANX 514-01 |
Study First Received: | April 18, 2008 |
Last Updated: | May 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00664170 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Estonia: Ravimiamet State Agency of Medicines |
Docetaxel Hydroxyzine |
Docetaxel Neoplasms Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |