Study identifier:D5082C00003
ClinicalTrials.gov identifier:NCT03091192
EudraCT identifier:2016-004108-73
CTIS identifier:N/A
A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib versus Sunitinib in Patients with MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)
Carcinoma, Kidney Diseases
Phase 3
No
Savolitinib, Sunitinib
All
60
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
Hutchinson MediPharma (HMP)
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Savolitinib See: intervention description | Drug: Savolitinib 600 mg (400 mg if <50 kg) by mouth (PO) with a meal once daily (QD), continuously Other Name: AZD6094 (HMPL-504)/Volitinib |
Active Comparator: Sunitinib See: intervention description | Drug: Sunitinib 50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off |