Savolitinib vs. Sunitinib in MET-driven PRCC.

Part of paid clinical trials in La Jolla, California.

Sponsor
AstraZeneca
Study ID
NCT03091192
Phase
PHASE3
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Savolitinib — DRUG
    600 mg (400 mg if \<50 kg) by mouth (PO) with a meal once daily (QD), continuously
  • Sunitinib — DRUG
    50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off

Study Details

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.

Key Dates

Start date
Jul 25, 2017
Status verified
Apr 2026
Primary completion
Aug 18, 2019
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib
    See: intervention description
  • Active Comparator: Sunitinib
    See: intervention description

Primary Outcome Measure

Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) [ Time Frame: RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR. ]

Locations (8)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteAtlantaGeorgia30322-
Research SiteChicagoIllinois60637-
Research SiteIowa CityIowa52242-
Research SiteBostonMassachusetts02215-
Research SiteKansas CityMissouri64132-
Research SiteNew YorkNew York10021-
Research SiteNashvilleTennessee37203-

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