Study Comparing Savolitinib and Sunitinib for MET-driven Papillary Renal Cell Carcinoma (PRCC)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03091192

Provider View

This clinical trial is testing a new cancer medication, savolitinib, to see if it is effective in treating patients with MET-driven Papillary Renal Cell Carcinoma (PRCC) and how it compares to the commonly used drug sunitinib.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new investigational medication called savolitinib for treating patients with MET-driven Papillary Renal Cell Carcinoma (PRCC) that cannot be surgically removed or has spread to other parts of the body. The study will compare savolitinib to sunitinib, a medication often used for this type of cancer, and will also look at the side effects of both treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Papillary Renal Cell Carcinoma (PRCC) that cannot be surgically removed or has spread, with measurable disease.
  • Confirmed MET-driven PRCC without certain genetic mutations (FH or VHL) from a tumor sample.
  • Can be new to treatment or have had previous treatment for advanced PRCC, but must not have received sunitinib or a MET inhibitor before.
  • Must have good blood, kidney, heart, and liver function.
  • Must be in good general health with a performance status score of 80 or higher.

Exclusion Criteria

  • Recent treatment with chemotherapy, immunotherapy, or investigational drugs within 28 days before starting the study.
  • Previous treatment with a MET inhibitor or sunitinib.
  • Use of certain medications that affect liver enzymes within 2 weeks before starting the study.
  • Recent radiation therapy or major surgery within 28 days before starting the study.
  • Untreated brain metastases.
  • Serious active infections or digestive diseases.
  • Other active cancers or treatment for invasive cancer in the past 5 years.
  • Heart rhythm issues or family history of sudden death related to heart problems.

Locations

FACILITYZIPCITYSTATE
Research Site92093La JollaCalifornia
Research Site30322AtlantaGeorgia
Research Site60637ChicagoIllinois
Research Site52242Iowa CityIowa
Research Site02215BostonMassachusetts
Research Site64132Kansas CityMissouri
Research Site10021New YorkNew York
Research Site37203NashvilleTennessee

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