Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 5:32 PM
Study NCT ID:
NCT01055795
Status:
COMPLETED
Last Update Posted:
2012-12-24
First Post:
2010-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Bevacizumab, Everolimus and LBH589 (BEL) for Advanced Solid Tumors
Sponsor:
Herbert Hurwitz
Organization:
Study Overview
Official Title:
Phase I Study of the Combination of Bevacizumab, Everolimus and LBH589 (BEL) for the Treatment of Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2012-12
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:
BEL
Brief Summary:
The main purpose of this study is to test the safety of three study drugs, bevacizumab (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It is hoped this study drug combination might lead to a greater decrease the in size of the cancer and/or slow down how fast the cancer is growing compared to when these drugs are given alone.
Subjects will be enrolled at Duke University Medical Center (DUMC).
Subjects will be enrolled at Duke University Medical Center (DUMC).
Detailed Description:
The main purpose of this study is to test the safety of three study drugs, bevacizumab (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It is hoped this study drug combination might lead to a greater decrease the in size of the cancer and/or slow down how fast the cancer is growing compared to when these drugs are given alone.
There are two parts of the study.
The purpose of part I is to find out the highest and safest levels of these drugs when they are given together. If you are enrolled in part I of the study, you will start all the study drugs at the same time. The amount (dose) of drugs you will get will depend on when you enter the study.
The purpose of part II is to see what effects, good and/or bad, the study drugs have when they are given alone and together. In addition, this will also give us a better understanding of how these study drugs work on you and your cancer. If you are enrolled in part II of the study, you will enter one of three study drug arms:
Study Drug Arm A: You will receive everolimus alone for two weeks, then add bevacizumab and LBH589 to your study regimen.
Study Drug Arm B: You will receive LBH589 alone for two weeks, then add bevacizumab and LBH589 to your study regimen.
Study Drug Arm C: You will receive everolimus and LBH589 together for two weeks, then add bevacizumab to your study regimen.
ABOUT THE STUDY DRUGS:
* Bevacizumab (Avastin™) is an intravenous (I.V., meaning through a vein) medication made from a special type of human and mouse protein called antibodies. Bevacizumab blocks a factor called VEGF (vascular endothelial growth factor) which is important for angiogenesis (the growth of new blood vessels). Blocking this factor is thought to block the growth of tumor-related blood vessels which may stop the growth of cancer. Bevacizumab and other drugs that block VEGF activity are currently being evaluated in clinical research studies in a variety of cancers.
* Everolimus (Afintor™) is a pill that works by blocking the activity of a substance in the body known as mTOR (mammalian target of rapamycin). mTOR is important for helping the growth and survival in normal and cancer cells. Blocking mTOR activity has been shown to slow or kill cancer cells in laboratory studies. Everolimus and other drugs that block mTOR activity are currently being evaluated in clinical research studies in a variety of cancers.
* LBH589 (Panobinostat) is a new pill that works by blocking a special group of proteins called histone deacetylases (HDACs). HDACs are important for helping the growth and survival in normal and cancer cells and for helping the growth of new tumor-related blood vessels. Blocking HDAC activity has been shown to shown to slow or kill cancer cells in laboratory studies. LBH589 and other drugs that block HDACs activity are currently being evaluated in clinical research studies in a variety of cancers. LBH589 (Panobinostat) is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer is therefore considered an investigational drug.
There are two parts of the study.
The purpose of part I is to find out the highest and safest levels of these drugs when they are given together. If you are enrolled in part I of the study, you will start all the study drugs at the same time. The amount (dose) of drugs you will get will depend on when you enter the study.
The purpose of part II is to see what effects, good and/or bad, the study drugs have when they are given alone and together. In addition, this will also give us a better understanding of how these study drugs work on you and your cancer. If you are enrolled in part II of the study, you will enter one of three study drug arms:
Study Drug Arm A: You will receive everolimus alone for two weeks, then add bevacizumab and LBH589 to your study regimen.
Study Drug Arm B: You will receive LBH589 alone for two weeks, then add bevacizumab and LBH589 to your study regimen.
Study Drug Arm C: You will receive everolimus and LBH589 together for two weeks, then add bevacizumab to your study regimen.
ABOUT THE STUDY DRUGS:
* Bevacizumab (Avastin™) is an intravenous (I.V., meaning through a vein) medication made from a special type of human and mouse protein called antibodies. Bevacizumab blocks a factor called VEGF (vascular endothelial growth factor) which is important for angiogenesis (the growth of new blood vessels). Blocking this factor is thought to block the growth of tumor-related blood vessels which may stop the growth of cancer. Bevacizumab and other drugs that block VEGF activity are currently being evaluated in clinical research studies in a variety of cancers.
* Everolimus (Afintor™) is a pill that works by blocking the activity of a substance in the body known as mTOR (mammalian target of rapamycin). mTOR is important for helping the growth and survival in normal and cancer cells. Blocking mTOR activity has been shown to slow or kill cancer cells in laboratory studies. Everolimus and other drugs that block mTOR activity are currently being evaluated in clinical research studies in a variety of cancers.
* LBH589 (Panobinostat) is a new pill that works by blocking a special group of proteins called histone deacetylases (HDACs). HDACs are important for helping the growth and survival in normal and cancer cells and for helping the growth of new tumor-related blood vessels. Blocking HDAC activity has been shown to shown to slow or kill cancer cells in laboratory studies. LBH589 and other drugs that block HDACs activity are currently being evaluated in clinical research studies in a variety of cancers. LBH589 (Panobinostat) is not approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer is therefore considered an investigational drug.
Study Oversight
Has Oversight DMC:
True
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?: