Trial Summary
What is the purpose of this trial?Researchers are doing this study to find out if the combination of the drugs axitinib and talazoparib is a safe and effective treatment for people with your previously treated advanced kidney cancer. Researchers will look for the highest dose of talazoparib that causes few or mild side effects when given in combination with a standard dose of axitinib.
Eligibility Criteria
Adults with advanced kidney cancer that's been treated before can join this trial. They must have had specific prior treatments, no severe liver issues, and be generally well enough to do daily activities. Pregnant women or those who've had certain other cancers recently can't participate.Inclusion Criteria
My blood counts meet the required levels and I haven't had a blood transfusion in the last 21 days.
My kidney cancer cannot be removed by surgery and has a clear cell component.
My kidneys work well enough, with a filtration rate of at least 60 ml/min.
+9 more
Exclusion Criteria
I do not have unmanaged fluid buildup.
I am currently on IV antibiotics for an infection.
I cannot take pills, have allergies to talazoparib/axitinib, or have a condition affecting my gut's ability to absorb medications.
+17 more
Participant Groups
The study tests a combo of two drugs, Talazoparib and Axitinib, for safety and effectiveness in treating advanced kidney cancer. The right dose of Talazoparib with fewer side effects is being sought while using a standard dose of Axitinib.
4Treatment groups
Experimental Treatment
Group I: Phase Ib, Dose Level 3Experimental Treatment2 Interventions
3-6 participants
Group II: Phase Ib, Dose Level 2Experimental Treatment2 Interventions
3-6 participants
Group III: Phase Ib, Dose Level 1Experimental Treatment2 Interventions
3-6 participants
Group IV: Phase II, Dose ExpansionExperimental Treatment2 Interventions
Optimal Simon 2-stage Design (14 participants initially, if MTD is tolerated well then accrual will go up to 25 participants)
Axitinib is already approved in European Union, United States, United Kingdom for the following indications:
🇪🇺 Approved in European Union as Inlyta for:
- Renal cell carcinoma
🇺🇸 Approved in United States as Inlyta for:
- Advanced renal cell carcinoma
🇬🇧 Approved in United Kingdom as Inlyta for:
- Advanced renal cell carcinoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memoral Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, NJ
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor