Abemaciclib + Cabozantinib for Kidney Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot take certain medications like moderate or strong CYP3A4 inducers or inhibitors, and some anticoagulants. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What data supports the effectiveness of the drug combination Abemaciclib and Cabozantinib for kidney cancer?
Cabozantinib has been shown to be effective in treating advanced kidney cancer, improving survival and response rates in patients, as seen in the METEOR trial. It is approved for use in advanced kidney cancer, which suggests it could be beneficial when combined with other treatments like Abemaciclib.12345
What safety information is available for cabozantinib in combination treatments?
What makes the drug combination of Abemaciclib and Cabozantinib unique for kidney cancer?
The combination of Abemaciclib and Cabozantinib is unique for kidney cancer because it combines two different mechanisms: Abemaciclib, a CDK4/6 inhibitor that blocks cancer cell division, and Cabozantinib, a tyrosine kinase inhibitor that targets multiple pathways involved in cancer growth and resistance. This dual approach may offer a novel way to tackle kidney cancer compared to existing treatments that typically focus on single pathways.1481011
What is the purpose of this trial?
The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.
Research Team
Martin Voss, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for individuals with metastatic clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. Participants should not have had previous treatments that failed and must be in good physical condition to handle the study drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive escalating doses of abemaciclib and cabozantinib to determine the maximally tolerated dose
Dose Expansion
Participants receive the determined dose of abemaciclib and cabozantinib to evaluate safety and effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Abemaciclib and Cabozantinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD