Clinical Trial: Savolitinib vs. Sunitinib in MET-driven PRCC

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: AstraZeneca

Current Primary Outcome: Progression Free Survival (PFS) [ Time Frame: Up to approximately 32 months after 1st patient randomized (121 PFS occurrences) ]

Time from randomisation to progression or death (PFS)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Survival (OS) [ Time Frame: Up to approximately 47 months after 1st patient randomized (121 OS occurrences) ]
    Time from the date of a patient's randomisation until death due to any cause
  • Objective Response Rate (ORR) [ Time Frame: Up to approximately 32 months after 1st patient randomized (at the time of PFS analysis) ]
    The proportion of patients achieving a complete or partial tumour response according to RECIST 1.1 criteria
  • Duration of Response (DoR) [ Time Frame: Up to approximately 32 months after 1st patient randomized (at the time of PFS analysis) ]
    The time from first documented tumour response until the date of documented progression or death from any casue
  • Disease Control Rate (DCR) [ Time Frame: At 6 and 12 months following the date of randomisation ]
    The proportion of patients achieving a complete response or partial response or stable disease according to RECIST 1.1 criteria
  • The plasma concentration-time data will be analysed by non-linear mixed effects modelling in order to evaluate the pharmacokinetic characteristics of savolitinib [ Time Frame: Cycle 1 Day 1 - pre-dose; Cycle 1 Day 15 - pre-dose and 1 and 3 hours post-dose; Cycle 1 Day 29 - pre-dose; Cycle 2 Day 15 - pre-dose ]
    Blood samples will be collected at various timepoints from patients receiving savolitinib
  • Mean change from baseline in FKSI-19 (Cancer Therapy Kidney Symptom Index-19) score [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, or end of treatment, whichever came first, assessed up to approximately 32 months ]
  • Mean change from baseline in FACIT-F (Functional Assessment of Chronic Illness Therapy - Fatigue) score [ Time Frame: From date of randomization until the date of first documented progression, date of death from any cause, or end of treatment, whichever came first, assessed up to approximately 32 months ]
  • Best percentage change in tumour size [ Time Frame: Up to approximately 32 months after 1st patient randomized (at the time of PFS analysis) ]
    The maximum reduction from baseline or the minimum increase from baseline in the absence of a reduction according to RECIST 1.1 criteria


Original Secondary Outcome: Same as current

Information By: AstraZeneca

Dates:
Date Received: February 9, 2017
Date Started: May 17, 2017
Date Completion: February 19, 2021
Last Updated: March 21, 2017
Last Verified: March 2017