Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01470209
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2011-10-25
Brief Title:
A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
A Phase I Study of BKM120 and Everolimus in Advanced Solid Malignancies
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 patients response to the treatment The investigators want to find out what effects good or bad the drugs have on the patients cancer
This study will also look at specific biomarkers in the patients 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 patients 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
Another purpose of this study is to determine the effectiveness and side effects of the combination of RAD001 and BKM120 by looking at the patients response to the treatment The investigators want to find out what effects good or bad the drugs have on the patients cancer
This study will also look at specific biomarkers in the patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WCI1925-10 | OTHER | Other | None |