A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma
Status:
Recruiting
Trial end date:
2024-11-05
Target enrollment:
Participant gender:
Summary
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.