HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast Cancer

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT00719875
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vorinostat — DRUG
    BID days -7, 1-7 and 15-21, 200 mg

Study Details

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.

Key Dates

Start date
Dec 31, 2008
Status verified
Mar 2017
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

To determine the safety, dose-limiting toxicities and maximum tolerated dose of oral capecitabine in combination with oral vorinostat given twice a day and to determine the objective response rate using RECIST criteria [ Time Frame: Upon completion of study ]

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University School of MedicineNew HavenConnecticut06219-

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Yale University School of Medicine· New Haven, CT

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