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Sponsored by: |
Adventrx Pharmaceuticals |
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Information provided by: | Adventrx Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00434369 |
A multi-center, open-label, single-arm Phase II trial assessing the efficacy and safety of weekly bolus infusions of 5-fluorouracil combined with CoFactor (5-10 methylenetetrahydrofolate) in advanced breast cancer patients who failed anthracycline and taxane chemotherapy regimens.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: CoFactor (ANX-510) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Open-Label, Single-Arm Phase II Trial Assessing the Efficacy and Safety of Weekly Bolus Infusions of 5-Fluorouracil Combined With CoFactor (5-10 Methylenetetrahydrofolate) in Advanced Breast Cancer Patients Who Failed Anthracycline and Taxane Chemotherapy Regimens |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as shown by the following:
Exclusion Criteria:
Argentina | |
Clinical Research Site in | |
Buenos Aires, Argentina | |
Mexico | |
Clinical Investigative Site | |
Acapulco, Mexico | |
Peru | |
Clinical Investigative Site | |
Lima, Peru | |
Russian Federation | |
Clinical Investigative Site | |
St.Petersburg, Russian Federation | |
Clinical Research Site in | |
Kazan, Russian Federation | |
Spain | |
Clinical Investigative Site | |
Valencia, Spain |
Study ID Numbers: | 510-08 |
Study First Received: | February 7, 2007 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00434369 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Hydroxyzine Immunologic Factors Skin Diseases Fluorouracil |
Breast Neoplasms Immunosuppressive Agents Taxane Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Fluorouracil Therapeutic Uses Breast Diseases |