Clinical Trial TitleStudy of ME-401 in subjects with follicular lymphoma after failure of two or more prior therapies.
Clinical Trial Protocol Description:
Follicular lymphoma (FL) is a cancer of lymphocytes, a type of white blood cell. The natural history of FL is characterized by multiple relapses. Progression-free survival (PFS) decreases after each line of treatment to less than a year after the fourth line of treatment.
ME-401 is an oral inhibitor of the delta isoform of PI3K with potential anti-cancer activity. This PI3K-delta inhibitor selectively inhibits the delta isoform of PI3K and prevents the activation of the PI3K/AKT signaling pathway. This both decreases cell growth and induces cell death in PI3K-delta-overexpressing cancer cells.
The main purpose of this study is to learn how well ME-401 works on controlling FL, to learn about the safety of the drug, and to compare the safety of 2 different schedules of administration. Patients being asked to take part in this study have been diagnosed with follicular lymphoma that has progressed after at least 2 prior systemic therapies.
The study is composed of 2 treatment groups, Group A and Group B; the difference between them is the schedule of when ME-401 is taken. Subjects are assigned to Group A or Group B by randomization, that is by chance, like the toss of a coin. The study doctor, study site staff, and the participating subject will not know if they are assigned to Group A or Group B.
All subjects receive one capsule of ME-401 at 60 milligrams taken once a day for 2 cycles of 28 days each, for a total of 56 days. After that period, subjects in Group A and Group B will have differing schedules of study drug.
Participating subjects may be in this study for about 2 years. Their participation in the study could be shorter or longer based on how well their lymphoma responds to ME-401 and how they tolerate treatment with ME-401.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 18 years of age or older and have a confirmed diagnosis of FL.
- Have disease that has progressed after at least 2 previous treatment regimens.
- Have adequate organ function.
You will be excluded from the study if any of the following criteria apply to you:
- Have had major surgery within 4 weeks of Day 1 treatment.
- Have any uncontrolled clinically significant illness such as active infection, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
- Have a history of clinically significant cardiovascular abnormalities or gastrointestinal (GI) conditions.
This is a partial list of inclusion and exclusion criteria.