Everolimus
DrugEverolimus will be administered orally at a 10 mg daily dose.
NCT Number: NCT01442090
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Bordeaux, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Everolimus will be administered orally at a 10 mg daily dose.
GDC-0980 will be administered orally at a 40 mg daily dose.
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
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)
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
Time frame: pre-dose on Week 1 Day 1, Week 1 Day 2, Week 3 Day 1 and Week 9 Day 1
Time frame: pre-dose on Week 1 Day 1 and Week 9 Day 1
Time frame: up to 30 days after end of treatment (approximately up to 23 months)
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Time frame: Baseline until disease progression or death, whichever occurred first (up to approximately 23 months)
Time frame: Baseline until death (up to approximately 45 months)
Genentech, Inc.
Industry
A Phase II, Open-Label, Randomized Study of GDC-0980 Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed on or Following VEGF-Targeted Therapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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