Study PIM4973g is a multicenter, international, open-label Phase II trial. Participants with metastatic renal cell carcinoma who have progressed on or after VEGF targeted therapy will be randomized in 1:1 to two groups either to receive daily GDC-0980 or everolimus orally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Everolimus will be administered orally at a 10 mg daily dose.
GDC-0980 will be administered orally at a 40 mg daily dose.
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
DUration of progression-free survival (PFS) as assessed by the investigator using RECIST v1.1
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Maximum plasma concentration (Cmax) of GDC-0980
Time frame: pre-dose and 1, 2, 4 hours post-dose on Week 1 Day 1, Pre-dose on Week 1 Day 2, pre-dose and 2 hours post dose on Week 3 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)
Cmax of everolimus
Time frame: pre-dose and 2, hours post-dose on Week 1 Day 1 and Week 9 Day 1, 48 hours after last dose (up to approximately 23 months)\n
Minimum plasma concentration (Cmin) of GDC-0980
Time frame: pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1
Cmin of everolimus
Time frame: pre-dose on Week 1 Day 1 and Week 9 Day 1
Number of participants with adverse events
Time frame: up to 30 days after end of treatment (approximately up to 23 months)
Number of participants with objective tumor response as assessed by the investigator using RECIST v1.1
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Duration of objective tumour response as assessed by the investigator using RECIST v1.1
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Duration of overall survival (OS)
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Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Las Vegas, Nevada, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Durham, North Carolina, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Nashville, Tennessee, United States
Unnamed facility
Bordeaux, France
Unnamed facility
Paris, France
...and 12 more locations
Time frame: Baseline until death (up to approximately 45 months)