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NCT01010854 · ClinicalTrials.gov registry record · Phase 2
Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01010854 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 6 participants.
The verdict
NCT01010854, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The addition of Valproic Acid to chemotherapy has been studied in about 65 subjects with cancer and was found to be safe and tolerable. Valproic Acid is approved by the Food and Drug Administration (FDA) for the treatment of seizures, mood swings, and migraine headaches. It is not currently approved for cancer, which is why the investigators are conducting this study. The results of a Phase I study of Valproic Acid and FEC100 in subjects with cancer that has spread has led the investigators to believe that this combination is better than just the standard treatment alone. The investigators are now testing the combination in a study with subjects who have either a large tumor, many lymph nodes involved or patients whose tumor has spread. In addition to the treatment, a main goal of the study is to find out which subjects will benefit from this combination. In the Phase I trial the investigators noticed that while this combination appears to make the chemotherapy more effective, it did not appear to cause more side effects induced by the chemotherapy.
Interventions
- DRUG VPA FEC100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2008-12-10 |
| Est. Completion | 2011-07-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01010854
The ClinicalTrials.gov registry entry for NCT01010854 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VPA FEC100 is the first listed.
NCT01010854 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01010854 about?
NCT01010854 is a clinical study titled "Valproic Acid in Combination With FEC100 for Primary Therapy in Patients With Breast Cancer". The drugs FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) are one of the approved options to treat Locally Advanced or Primary Metastatic Breast Cancer. In this study, the investigators will add another drug called Valproic Acid (VPA) to see whether this makes the treatment better. The ad...
What is the current status of trial NCT01010854?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2008-12-10. Estimated completion is 2011-07-29.
What interventions are being tested in trial NCT01010854?
The interventions under investigation include: VPA FEC100 (DRUG).
Who is sponsoring clinical trial NCT01010854?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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