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Tyrosine Kinase Inhibitor

Multiple Drugs for Advanced Kidney Cancer

Phase 2

Waitlist Available

Led By Sumanta K Pal

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying four different drugs to see how well they work in treating patients with kidney cancer that has spread.

Who is the study for?

This trial is for adults with advanced or metastatic papillary renal cell carcinoma, which can't be surgically removed. They may have had one prior systemic therapy (excluding certain VEGF inhibitors) and must have recovered from its effects. No MET/HGF inhibitors or sunitinib as previous treatments are allowed, and they should not be on strong CYP3A4 inhibitors/inducers.

What is being tested?

The effectiveness of cabozantinib s-malate, crizotinib, savolitinib, or sunitinib malate in treating kidney cancer that has spread is being tested. These drugs aim to block enzymes necessary for tumor growth. The study will determine if any drug works better than the others.

What are the potential side effects?

Potential side effects include fatigue, diarrhea, high blood pressure, hand-foot syndrome (redness and pain in hands and feet), mouth sores, nausea/vomiting; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Survival (OS)

Response Rate (RR)

Other study objectives

MET Mutation Rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (savolitinib closed to accrual 12/5/18)Experimental Treatment4 Interventions

Patients receive savolitinib PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.

Group II: Arm III (crizotinib closed to accrual 12/5/18)Experimental Treatment4 Interventions

Patients receive crizotinib PO BID on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.

Group III: Arm II (cabozantinib s-malate)Experimental Treatment4 Interventions

Patients receive cabozantinib s-malate PO QD on days 1-42. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.

Group IV: Arm I (sunitinib malate)Experimental Treatment4 Interventions

Patients receive sunitinib malate PO QD on days 1-28. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT at screening and on study, undergo bone scan as clinically indicated, and undergo collection of plasma and serum samples at screening, on study, and during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sunitinib Malate

2008

Completed Phase 3

~3070

Crizotinib

2014

Completed Phase 3

~2960