Savolitinib vs. sunitinib in MET-driven PRCC.

Study identifier:D5082C00003

ClinicalTrials.gov identifier:NCT03091192

EudraCT identifier:2016-004108-73

CTIS identifier:N/A

Recruitment Complete

Official Title

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)

Medical condition

Carcinoma, Kidney Diseases

Phase

Phase 3

Healthy volunteers

No

Study drug

Savolitinib, Sunitinib

Sex

All

Actual Enrollment

60

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 25 Jul 2017
Primary Completion Date: 18 Aug 2019
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Hutchinson MediPharma (HMP)

Inclusion and exclusion criteria