The purpose of this study is to determine the safety, tolerability, and maximal tolerated
dose (MTD) of the combination of Abemaciclib and Sunitinib administered orally in patients
with advanced and metastatic renal cell carcinoma. This study consists of two parts: Dose
Escalation and Dose Expansion. During the dose escalation phase, participants will be
sequentially enrolled in a standard 3 x 3 dose escalation study design to receive oral
Abemaciclib in Combination with Sunitinib. The purpose of this dose escalation is to
determine the maximal tolerated dose based on assessment of any dose limiting toxicity. The
Dose Expansion Phase will enroll additional participants at the established maximal tolerated
dose to further evaluate safety, tolerability, as well as the pharmacokinetics and
pharmacodynamics of this combination drug regimen.
Renal cell carcinoma (RCC) accounted for about 64, 000 new cancer diagnoses in the USA in
2018. Up to 30% of those diagnoses will be patients with metastatic disease. Additionally, up
to 50% of patients who undergo partial or radical nephrectomy will develop metastatic
disease.. There is no cure for metastatic RCC, thus, metastatic RCC represents a significant
cancer burden. Numerous directed therapies are available to improve overall survival but
these do not result in durable complete responses. However, recent pre-clinical studies of
RCC have demonstrated that Abemaciclib, a CDK4/6 and PIM1 kinase inhibitor, induces rapid,
dramatic, and sustained tumor regression when used in combination with Sunitinib.
Our objectives for this study are as follows:
Determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of
the combination of Abemaciclib with Sunitinib for patients with metastatic renal cell
carcinoma. Additionally, determine pharmacokinetics (serum trough levels) of Abemaciclib
and Sunitinib at steady state.
Continued safety assessment of the combination of Abemaciclib and Sunitinib at the
established maximum tolerated dose (i.e. the recommended Phase II dose)
Determine any anti-tumor activity in the dose expansion phase of the study. Tumor related
activity will be assessed by:
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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