This research study will assess whether abemaciclib alone or in combination with MK-6482 are
safe and effective in slowing down the growth of clear cell renal cell carcinoma (ccRCC).
The names of the study drugs in this investigational combination are:
This a two-arm, non-randomized phase 1/1B trial aiming at assessing the safety and activity
of abemaciclib alone (arm 1), and abemaciclib plus MK-6482 (arm 2) in patients with advanced
refractory clear-cell renal cell carcinoma (croc).
A Phase I clinical trial tests the safety of an investigational drug or drug combination and
also tries to define the appropriate dose of the investigational drug or drug combination to
use for further studies. "Investigational" means that the drug is being studied.The U.S. Food
and Drug Administration (FDA) has not approved either abemaciclib or MK-6482 for renal
(kidney) cancer but abemaciclib has been approved to treat other forms of cancer.
Abemaciclib is in a class of drugs known as CDK4 & 6 inhibitors. These proteins control how
fast cells grow and divide and are found on both normal and cancer cells. They become
overactive in cancer cells causing cells to grow and divide uncontrollably. Abemaciclib
blocks these proteins just as the cells start to grow and divide and in other cancers has
been shown to slow down cancer cell growth and division, causing cancer cells to become
inactive or even die.
MK-6482 is an oral, first-in-class selective small-molecule inhibitor that targets
hypoxia-inducible factor (HIF)-2a, which promotes the growth of new vessels that fuel kidney
This study is looking at two different treatments:
Arm 1 - abemaciclib alone:
To determine the response rate of abemaciclib alone in patients with advanced ccRCC
Arm 2 - combination therapy of abemaciclib and MK-6482
To determine the maximum dose of abemaciclib and MK-6482 in combination.
To determine the response rate of abemaciclib and MK-6482 in patients with advanced
The research study procedures include screening for eligibility, study treatment, participant
evaluations and safety follow-up visits, in addition to general health status follow-up after
study treatment. It is estimated that participants will receive 12 to 18 months of study
treatment and 3 months of safety follow-up, totaling about 15 to 21 months from the start of
study treatment. After the safety follow-up visits, the study doctor may request that
participants return to clinic for additional tumor assessments or his/her staff will contact
participants about every 6 months to follow their health status and find out about any
anticancer treatments participants may have begun after study treatment.
It is expected that about 40 people will take part in this research study.
The pharmaceutical company Eli Lilly is supporting this research study by providing funding
for the research study, tests required for research purposes only, and the study drugs. The
pharmaceutical company Merck is supporting this research study by providing study drug.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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