A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01470209
Protocol IDs
WCI1925-10 (primary)
Study Sponsor
Winship Cancer Institute of Emory University

Summary

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.

Objectives

The purpose of this study is to study the combination of two anticancer drugs, everolimus 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.