Status:
UNKNOWN
Clinical Trial of SAHA in Patients With Breast Cancer
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Purpose: * evaluate the safety of Vorinostat. * evaluate the effectiveness of Vorinostat in treating breast cancer * evaluate how the study subject's body reacts to Vorinostat, how these reactions re...
Detailed Description
Breast cancer is sensitive to a range of chemotherapeutics agents, but despite initial sensitivity, resistance typically emerges, resulting in disease relapse or progression. Exploration of novel clas...
Eligibility Criteria
Inclusion
- Key
- Cytologically or histologically confirmed adenocarcinoma of the breast that is recurrent and/or metastatic
- Must have measurable disease as defined by RECIST criteria
- No more than 2 prior chemotherapy for recurrent and/or metastatic disease excluding neoadjuvant or adjuvant chemotherapy
- Previously received anthracycline- and taxane-containing chemotherapy for treatment of breast cancer in the neoadjuvant, adjuvant, or metastatic setting
- Must be able to swallow capsules
- Adequate bone marrow reserve and liver function
- Women in reproductive age group must agree to practice effective contraception during the entire study period unless documentation of infertility exists.
- Key
Exclusion
- Prior treatment with any HDAC inhibitor. Patients who have received such agents for other indications, e.g. epilepsy, may enroll in the trial after a 30 day washout period.
- Known CNS involvement by tumor
- Concurrent use of oral retinoids or any vitamin A, other than a single multivitamin tablet daily
- Acute infection requiring intravenous antibiotics or antifungal agents,known HIV infection, active hepatitis B and/or hepatitis C infection
- Uncontrolled intercurrent illness
- Cancer other than breast cancer with the exception of basal cell carcinoma or disease that has been in remission for ≥5 years
- Pregnant or lactating women
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00416130
Start Date
January 1 2007
End Date
January 1 2015
Last Update
December 10 2013
Active Locations (2)
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1
National University Hospital
Singapore, Singapore, 149547
2
National Cancer Centre
Singapore, Singapore, 169610