A Study of Abemaciclib in Combination With Sunitinib in Metastatic Renal Cell Carcinoma

PHASE1TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

June 5, 2019

Primary Completion Date

March 8, 2022

Study Completion Date

March 8, 2022

Conditions
Renal Cell Carcinoma Metastatic
Interventions
DRUG

Abemaciclib

Subjects will by given oral Abemaciclib every 12 hours for 14 days followed by 7 days off (i.e. a 21 day cycle). The initial dose will be 100 mg (Dose level 1) followed by 150 mg (Dose Level 2) depending on tolerability and toxicity assessment of the combination of medications. If at Dose Level 1 subjects cannot tolerate the combination of medications, the Abemaciclib would not be increased, and the dose will remain stable at 100 mg (Dose Level -1).

DRUG

Sunitinib

Subjects will take oral Sunitinib daily for the 21-day cycle. Dosing will be at 50 mg for both Dose Levels 1 and 2. If the combination of the 2 medications is not tolerated by Subjects at Dose Levels 1 a lower dose of Sunitinib (37.5 mg) will be given (Dose Level -1).

Trial Locations (1)

02903

Rhode Island Hospital, Providence

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eli Lilly and Company

INDUSTRY

lead

Brown University

OTHER