A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies|
- Dose limiting toxicity [ Time Frame: During the first cycle of treatment; approximately 4 weeks ]
i. Grade 4 hematologic toxicity (excluding anemia) lasting more than 7 days
ii. Grade 3 anemia lasting more than 7 days or requiring blood transfusion
iii. Grade 4 anemia
iv. Grade ≥ 3 febrile neutropenia of any duration
v. Grade ≥ 3 nausea and or vomiting lasting more than 72 hours in spite of standard supportive therapy
vi. Grade ≥ 3 non-hematologic toxicity (excluding alopecia)
- Clinical benefit rate [ Time Frame: During the entire duration of therapy estimated to be an average of 6 months for each patient ]Sum of complete response, partial response and stable disease
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
|Experimental: Combination of BKM120 and everolimus||
BKM120 (20mg to 100mg) will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. BKM120 will be administered on a continuous once daily dosing schedule. Patients should be instructed to take the dose of BKM120 daily in the morning, one hour after a light breakfast (morning meal) at approximately the same time each day. BKM120 should be taken with a glass of water and consumed over as short a time as possible. Patients should swallow the capsules as a whole and not chew them. Patients should continue to fast for 2 hours after the administration of each BKM120 dose.
Other Name: BuparlisibDrug: Everolimus
RAD001 will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. RAD001 will be administered orally as once daily dose of 5mg or 10 mg (based on the dose cohort) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470209
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Taofeek Owonikoko, MD, PhD||Emory University Winship Cancer Institute|