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| Sponsor: | Yale University |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00719875 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Breast Cancer |
Drug: Vorinostat |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 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 |
| Estimated Enrollment: | 47 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Vorinostat
BID days -7, 1-7 and 15-21, 200 mg
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Contacts and Locations| Contact: Mary Beth Clark | 203-785-6822 | mary.clark@yale.edu |
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06219 | |
| Principal Investigator: Maysa Abu-Khalaf, M.D. | |
| Principal Investigator: | Maysa Abu-Khalaf, M.D. | Yale Unviversity School of Medicine |
More Information
| Responsible Party: | Yale University School of Medicine ( Maysa Abu-Khalaf, M.D. ) |
| Study ID Numbers: | 0803003591 |
| Study First Received: | July 18, 2008 |
| Last Updated: | June 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00719875 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Anti-Inflammatory Agents Anticarcinogenic Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Breast Diseases |
Capecitabine Skin Diseases Vorinostat Breast Neoplasms Enzyme Inhibitors Protective Agents Pharmacologic Actions Neoplasms Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |