Lung Cancer Clinical Trial
Official title:
A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies
This study will assess the safety of combining two agents (everolimus and BKM120) for the treatment of advanced cancer arising from solid organ in patients who are no longer benefiting from or unable to withstand standard treatment of these conditions.
The purpose of this study is to study the combination of two anticancer drugs, everolimus
(RAD001) and BKM120, in patients whose cancer is no longer responding to standard treatment
or patients who are unable to tolerate the standard treatment for their cancer. The
investigators seek to establish the safety of taking these two medications together and to
determine the appropriate doses of the two drugs when given together as well as identify
potential side effects when the drugs are administered together.
Another purpose of this study is to determine the effectiveness and side effects of the
combination of RAD001 and BKM120 by looking at the patient's response to the treatment. The
investigators want to find out what effects, good or bad, the drugs have on the patient's
cancer.
This study will also look at specific biomarkers in the patient's blood and in the tumor
tissue which are involved in the growth of tumor cells and determine if the levels of these
biomarkers are related to the patient's response to treatment or development of side effects.
Everolimus, also known by the brand name, Afinitor, is a biologic drug approved by the Food
and Drug Administration (FDA) for the treatment of kidney cancer. It works by preventing
cancer cell from multiplying and it also renders them easily susceptible to death.
BKM120 is a new study drug that is being tested for its ability to treat cancer. However, it
has not yet been approved by the FDA for the treatment of any specific cancer type.
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