|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Adventrx Pharmaceuticals |
|---|---|
| Information provided by: | Adventrx Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00434369 |
Purpose
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 |
Eligibility| 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:
Contacts and Locations| 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 | |
More Information
| 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 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 |