Defining the Triple Negative Breast Cancer Kinome Response to GSK1120212
|ClinicalTrials.gov Identifier: NCT01467310|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: GSK1120212||Early Phase 1|
In this study the investigators want to look at the activity of kinases when a particular experimental drug called GSK1120212 is administered. GSK1120212 blocks a kinase called MEK. GSK1120212 is not yet approved by the FDA for use in breast cancer patients. The investigators want to give subjects GSK1120212 for a short period of time (one week) to see how MEK and the other kinases function in cancer cells both before and after the study drug is given. The investigators are giving this drug for research purposes only. The length of time it is being given is not intended to treat cancer.
Research into treatments for breast cancer relies more and more on an understanding of how the cells of tumor tissue act when they are exposed to a new or different drug. To find these new or different drugs to treat cancer, researchers are looking at proteins that help cancer cells grow, such as a group of proteins called Kinases. This is important because many of the newest cancer drugs are designed to block kinases causing the cancer cells to die and the tumors to shrink. However, blocking only one of the kinases at a time is often less effective than the investigators expected because when you block one kinase another can take its place. For this reason, the investigators may need to treat breast cancer with more than one kinase-blocking drug at a time. However, the investigators don't yet know what the best combination of drugs should be, because it is hard to measure all the possible kinases. Previous studies have only been able to identify less than 10% of the hundreds of kinases in cancer cells.
Recently researchers here at UNC have developed a process that can identify may (more than half) of these kinases. This can tell us which kinases need to be blocked at the same time to make tumors shrink so that the investigators can design the best combinations of kinase blocking drugs for triple negative breast cancer. This is especially important for individuals with triple negative breast cancer (TNBC) because there are fewer drugs available that can block molecules that affect tumor growth. The investigators believe that kinase-blocking drugs have the potential to be a more effective treatment for people with TNBC.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Defining the Triple Negative Breast Cancer Kinome Response to GSK1120212|
|Study Start Date :||January 2012|
|Primary Completion Date :||April 2016|
|Study Completion Date :||April 2016|
1.5 to 2.0 mg taken orally every day for seven days.
- the number and type of kinases in participant tissue sample prior to administration of drug compared to post-treatment. [ Time Frame: Two years ]use of pan kinase inhibitors immobilized on beads to capture expressed kinases in cells and tumors. The activation state of more than 60% of the expressed kinome, defined by RNA-seq, will be analyzed using mass spectrometry analysis of the captured kinases.
- the number and type of kinases that produce a compensatory response to MEK inhibitor [ Time Frame: Two years ]The activation state of more than 60% of the expressed kinome, defined by RNA-seq, will be analyzed using mass spectrometry analysis of the captured kinases. For each activated kinase, a drug therapy that combines an inhibitor of that kinase with a MEK inhibitor will be identified.
- the number of participants with adverse events [ Time Frame: Two years ]Identify any safety issues in subjects treated with drug GSK1120212
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467310
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Lisa Carey, MD||UNC Lineberger Comprehensive Cancer Center|