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Savolitinib vs. Sunitinib in MET-driven PRCC.

NCT03091192 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-14

Study results available
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Summary

This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

Conditions

  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Urologic Neoplasms
  • Kidney Diseases
  • Neoplasms by Site
  • Enzyme Inhibitors
  • Protein Kinase Inhibitors

Interventions

DRUG

Savolitinib

600 mg (400 mg if \<50 kg) by mouth (PO) with a meal once daily (QD), continuously

DRUG

Sunitinib

50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Toni K Choueiri, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2019-08-18
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • France
  • Italy
  • Russia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03091192 on ClinicalTrials.gov