Trials / Completed
CompletedNCT00719875
HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer
A Dose-escalating and Phase II Clinical Trial of the Histone Deacetylase (HDAC) Inhibitor Vorinostat (Suberoylanilide Hydroxamic Acid, SAHA, ZolinzaTM) in Combination With Capecitabine (XelodaTM) Using a New Weekly Dose Regimen for Advanced Breast Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Yale University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Vorinostat | BID days -7, 1-7 and 15-21, 200 mg |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2008-07-22
- Last updated
- 2017-03-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00719875. Inclusion in this directory is not an endorsement.