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NCT00719875 · ClinicalTrials.gov registry record · Phase 1
HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00719875 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 24 participants.
The verdict
NCT00719875, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study was originally intended to be a phase 1/phase 2. The protocol was amended to make this study a phase 1 only.
Interventions
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00719875
The ClinicalTrials.gov registry entry for NCT00719875 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vorinostat is the first listed.
NCT00719875 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00719875 about?
NCT00719875 is a clinical study titled "HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer". The purpose of this study is to determine the safety profile, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), of oral vorinostat in combination with oral capecitabine given on days 1-7 and 15-21 of a 28 day cycle in patients with advanced breast cancer, using RECIST criteria. This study...
What is the current status of trial NCT00719875?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-12. Estimated completion is 2013-06.
What interventions are being tested in trial NCT00719875?
The interventions under investigation include: Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00719875?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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