Clinical Trial of SAHA in Patients With Breast Cancer

• Status: Unknown status
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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 relate to the subject's genes, and whether protein changes in the subject blood may be used to predict how the subject's cancer will respond to Vorinostat

We hypothesize that Vorinostat, as a novel class of anti-cancer agents, may induce response in patients with recurrent or metastatic breast cancer who have been previously treated with anthracyclines and taxanes. In addition, we hypothesize that serum Vorinostat levels may correlate with clinical response and toxicities, and that Vorinostat may induce unique protein changes in the plasma in responding patients, and that these proteins may in turn be used as predictive biomarkers for treatment response.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Vorinostat

Criteria

Key Inclusion Criteria:

• 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 Criteria:

• 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