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Tyrosine Kinase Inhibitor

Cabozantinib S-malate for Renal Cell Carcinoma

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

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

Overall Survival (OS)

Response Rate (RR)

Other outcome measures

MET Mutation Rate

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

Computed Tomography

2017

Completed Phase 2

~2720

Biospecimen Collection

2004

Completed Phase 2

~1730

Cabozantinib S-malate

2013

Completed Phase 2

~470

Savolitinib

2019

Completed Phase 1

~110

Sunitinib Malate

2008

Completed Phase 3

~3070

Crizotinib

2014

Completed Phase 3

~2370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,729 Total Patients Enrolled

Canadian Cancer Trials GroupNETWORK

124 Previous Clinical Trials

67,301 Total Patients Enrolled

Sumanta K PalPrincipal InvestigatorSWOG Cancer Research Network

9 Previous Clinical Trials

201 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is Cabozantinib S-malate as a therapeutic option?

"Cabozantinib S-malate has been issued a score of 2 by our in-house experts, as this is only Phase 2 trial and efficacy data need to be collected. Safety information exists however."

Answered by AI

Are there other precedents for utilizing Cabozantinib S-malate in clinical trials?

"At present, 217 clinical trials of Cabozantinib S-malate are in progress with 31 at the Phase 3 level. The Hub City for these studies is Chicago, Illinois; however, there a total of 15469 sites trialing this medication."

Answered by AI

What conditions has Cabozantinib S-malate been known to alleviate?

"Cabozantinib S-malate can be beneficial in the management of thyroid cancers, which have already been treated with anti-vegf, and malignant neoplasms."

Answered by AI

What is the cap on the amount of participants taking part in this trial?

"Unfortunately, the specified trial is not currently recruiting. It was first initiated on April 5th 2016 and last edited on August 2nd 2022. For those searching for more studies related to metastatic papillary renal cell carcinoma, there are 2580 trials actively recruiting participants in addition to 217 clinical trials with Cabozantinib S-malate as a potential intervention of interest."

Answered by AI

What is the geographical breadth of this study?

"Patients can join this trial at three main hospitals: Saint Mary's Regional Medical Center in Reno, Ohio, Mount Carmel East Hospital in Columbus, Texas, and Saint Ann's Hospital in Westerville, Illinois. There are also 100 other clinical sites taking part."

Answered by AI

What is the objective of this medical experiment?

"This medical trial, which will be assessed over a 3-year period from registration to progression or death due to any cause, intends to measure the Progression Free Survival (PFS) of its participants. Secondary outcomes include incidence of toxicity graded according to NCI Common Terminology Criteria for Adverse Events v5.0., Number of Participants With Grades 3 Through 5 Adverse Events Related To Study Drugs and Response Rate (RR)."

Answered by AI

Are enrollees still being welcomed for this investigation?

"According to the records on clinicaltrials.gov, this trial is no longer accepting participants. The initial post was published April 5th 2016 and the latest edit came August 2nd 2022. However, there are plenty of other medical studies actively seeking applicants - 2797 in total!"

Answered by AI

Recent research and studies

The LancetJournal

A Comparison of Sunitinib with Cabozantinib, Crizotinib, and Savolitinib for Treatment of Advanced Papillary Renal Cell Carcinoma: A Randomised, Open-label, Phase 2 Trial

Pal, Sumanta K, Catherine Tangen, Ian M Thompson Jr, Naomi Balzer-Haas, Daniel J George, Daniel Y C Heng, Brian Shuch, et al.. 2021. “A Comparison of Sunitinib with Cabozantinib, Crizotinib, and Savolitinib for Treatment of Advanced Papillary Renal Cell Carcinoma: A Randomised, Open-label, Phase 2 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(21)00152-5.

clinicaltrials.govStudy

Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed

2016. "Testing Cabozantinib, Crizotinib, Savolitinib and Sunitinib in Kidney Cancer Which Has Progressed". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02761057.

All > Kidney Cancer > Sutent