Savolitinib vs. Sunitinib for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+48 other locations

Overseen byToni K Choueiri, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with MET-driven, advanced Papillary Renal Cell Carcinoma (PRCC) that can't be surgically removed. It's open to those who haven't had treatment or have had previous systemic therapy. Participants need good blood, kidney, heart, and liver function and a high level of physical ability. They must not have other active cancers or recent cancer treatments, untreated brain metastases, or conditions affecting the heart's rhythm.

Inclusion Criteria

I have or haven't had systemic therapy for advanced PRCC.

My blood, kidney, heart, and liver functions are all within normal ranges.

I can carry out normal activities with minimal symptoms.

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Exclusion Criteria

I haven't had major surgery in the last 4 weeks or minor surgery in the last week.

My brain cancer has not been treated yet.

I have not had treatment for any invasive cancer in the last 5 years, nor do I have any other active cancers.

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Treatment Details

Interventions

Savolitinib (Kinase Inhibitor)
Sunitinib (Kinase Inhibitor)

Trial OverviewThe study compares Savolitinib (a new anti-cancer medication) with Sunitinib (an established treatment), in patients with PRCC to see which is more effective and what side effects they might cause. Patients will be randomly assigned to receive either drug and monitored for results.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: SavolitinibExperimental Treatment1 Intervention

See: intervention description

Group II: SunitinibActive Control1 Intervention

See: intervention description

Savolitinib is already approved in China for the following indications:

🇨🇳 Approved in China as Orpathys for: