A Trial of LEE011 in Patients With Advanced Solid Tumors or Lymphoma.
Status:
Completed
Trial end date:
2017-03-09
Target enrollment:
Participant gender:
Summary
LEE011 is a new oral drug designed to inhibit the activity of an enzyme known as CDK4/6.
CDK4/6 is involved in the process that allows both normal and cancer cells to divide and
multiply. Cancer cells are often driven to divide and multiply by abnormalities that increase
the activity of CDK4. Hence there is hope that blocking the activity of CDK4 may slow the
growth of some cancers. LEE011 has shown anti-cancer activity in several different tumor
models in animals.
Because CDK4 is important in both normal and cancerous cells, LEE011 is expected to decrease
the ability of the bone marrow to make white blood cells, platelets, and red blood cells.
Although these effects are expected to be reversible, they can increase the risk of
infection, bleeding and fatigue.
The primary purpose of this study is to find the highest dose of LEE011 that can be safely
given to adult patients with advanced solid tumors or lymphomas for which no further
effective standard treatment is available. It will provide information about the side effects
that may occur following treatment. The study will also possibly provide early evidence for
LEE011's anti-tumor activity.