A Phase I trial of oral 5-azacitidine in combination with romidepsin in advanced solid tumors, with an expansion cohort in non-small cell lung cancer
This research study is being done to determine if the investigational drug combination of 5-azacitidine and romidepsin are generally safe, tolerable and effective in people with advanced solid tumor cancer.
Adults (18 or above) with confirmed, measurable advanced solid tumors. Any solid tumor diagnosis is allowed in the dose escalation portion of study / non-small cell lung cancer only in the expansion portion of study. Discontinuation of cancer treatment within 4 weeks of taking study drugs (including chemotherapy, radiation therapy, hormonal therapy or surgery). Participants must have adequate performance status and blood counts (white cells and platelets), as well as kidney and liver functions. No prior cancers for at least 5 years except treated basal cell/squamous cell or the skin, or carcinoma in situ of the cervix/breast. Any known brain metastases must be treated and stable for at least 4 weeks and off steroids. No significant cardiac abnormalities allowed. Participants on warfarin blood thinner and other select medications are not eligible.
Each study cycle equals 28 days. Participants will take 5-azacitidine by mouth 14 or 21 days of a 28 day cycle. Romidepsine will be administered 2-3 times each 28 day cycle via intravenous infusion over 4 hours. Blood tests will be done frequently to assure adequate blood counts and electrolytes. Electrolyte replacement will be given if needed (such as potassium, magnesium). Anti nausea medication may also be administered.
09/20/2014 04:03 AM