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Kinase Inhibitor

Savolitinib vs. Sunitinib for Kidney Cancer

Phase 3

Waitlist Available

Led By Toni K Choueiri, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting

Karnofsky performance status ≥ 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up recist tumour assessments every 6 weeks from randomisation until disease progression as defined by recist 1.1 and confirmed by bicr.

Awards & highlights

Study Summary

This trial is for patients with a certain type of kidney cancer that has spread and cannot be removed by surgery. The goal is to see if a new medication, savolitinib, is better than the current standard of care, sunitinib, and to learn about any side effects.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects include issues related to the digestive system, liver toxicity, fatigue, skin reactions like hand-foot syndrome from Sunitinib; while Savolitinib may cause similar problems along with possible lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Select...

I can carry out normal activities with minimal symptoms.

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My cancer is MET-driven PRCC without FH or VHL mutations, confirmed by a specific test.

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My kidney cancer cannot be surgically removed and has spread, with measurable signs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ recist tumour assessments every 6 weeks from randomisation until disease progression as defined by recist 1.1 and confirmed by bicr.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~recist tumour assessments every 6 weeks from randomisation until disease progression as defined by recist 1.1 and confirmed by bicr.

This trial's timeline: 3 weeks for screening, Varies for treatment, and recist tumour assessments every 6 weeks from randomisation until disease progression as defined by recist 1.1 and confirmed by bicr. 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) by Blinded Independent Central Review (BICR)

Secondary outcome measures

Disease Control Rate (DCR) at 12 Months by BICR

Disease Control Rate (DCR) at 6 Months by BICR

Duration of Response (DoR) by BICR

+2 more

Side effects data

From 2017 Phase 2 & 3 trial • 78 Patients • NCT01164202

31%

Platelets

28%

Neutrophiles

26%

Bilirubine

23%

Asthenia

21%

ASAT

21%

ALAT

15%

Leucocytose

13%

Liver failure

13%

Hand-foot syndrome

10%

Abdominal pain

Anorexia

Fever

Increase GGT

Arterial hypertension

Encephalopathy

Phosphatases alcalines

Diarrhea

Ascite

Liver pain

Encephalopathia

Hemoglobine

Lumbar pain

Hemoglobin

Prothrombin time

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sunitinib

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SavolitinibExperimental Treatment1 Intervention

See: intervention description

Group II: SunitinibActive Control1 Intervention

See: intervention description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Savolitinib

2019

Completed Phase 1

~110

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,259 Previous Clinical Trials

288,593,842 Total Patients Enrolled

6 Trials studying Tumors

1,866 Patients Enrolled for Tumors

Hutchinson MediPharma (HMP)UNKNOWN

Toni K Choueiri, MDPrincipal InvestigatorDana-Farber Cancer Institute

4 Previous Clinical Trials

157 Total Patients Enrolled

Media Library

Savolitinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03091192 — Phase 3

Tumors Research Study Groups: Savolitinib, Sunitinib

Tumors Clinical Trial 2023: Savolitinib Highlights & Side Effects. Trial Name: NCT03091192 — Phase 3

Savolitinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03091192 — Phase 3

Frequently Asked Questions

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

What is the Savolitinib drug's official stance from the FDA?

"Savolitinib has undergone multiple rounds of testing and there is some data supporting efficacy, so it received a score of 3."

Answered by AI

Is this clinical trial also being conducted in other parts of the world?

"Currently, there are 8 clinics where this trial is recruiting patients from. The locations include Chicago, Boston and Kansas City as well other cities. If you enroll in the study, it would be beneficial to choose a clinic close to your residence to minimize travel needs."

Answered by AI

What makes this clinical study innovative?

"Savolitinib has a long research history, with the initial study being sponsored by Pfizer all the way back in 2006. After the first Phase 1 trial involving 64 patients, Savolitinib was approved for use in Phase 2 trials. There are currently 51 active studies conducted across 44 countries and 1127 cities."

Answered by AI

What is the track record of Savolitinib in other research projects?

"To date, there are 51 Savolitinib studies that are still recruiting patients. The majority of these trials are in their third phase of testing. Most of the clinical trials for Savolitinib are based in Tampa, Florida, however there are 4208 locations running studies for Savolitinib globally."

Answered by AI

Could you explain the inclusion criteria for this experiment?

"This clinical trial is testing the effects of a new cancer medication and is looking for neoplasms patients aged 18-130. A total of 60 people will be accepted into the study."

Answered by AI

What is the maximum capacity for this clinical trial?

"As of now, this study has completed recruitment for participants. The trial was first posted on July 25th, 2017 and last updated on November 10th, 2020. However, there are 5460 other trials that are actively looking for patients with neoplasms by site and 51 trials for Savolitinib admitting patients."

Answered by AI

What are the main benefits of Savolitinib?

"Savolitinib is frequently used to ameliorate soft tissue sarcoma, but it can also be taken as treatment for various other conditions like gastrointestinal stromal tumors and metastatic pancreatic neuroendocrine tumors."

Answered by AI

Does this particular research project restrict participants to a certain age group?

"This clinical trial includes a wide age range of potential participants, from 18 to 130 years old. There are 436 other trials specifically for people under the age of 18 and 5263 targeting patients over 65."

Answered by AI

Are participants being accepted into the trial at this time?

"Unfortunately, this study is not presently looking for candidates. The study was initially posted on 7/25/2017 and was most recently edited on 11/10/2022. However, there are other opportunities available; 5460 clinical trials actively recruiting participants with neoplasms by site and 51 studies for Savolitinib actively searching for patients."

Answered by AI

Recent research and studies

metJournal

Efficacy of Savolitinib Vs Sunitinib in Patients with <i>met</i>-driven Papillary Renal Cell Carcinoma

Choueiri, Toni K., Daniel Y. C. Heng, Jae Lyun Lee, Mathilde Cancel, Remy B. Verheijen, Anders Mellemgaard, Lone H. Ottesen, et al.. 2020. “Efficacy of Savolitinib Vs Sunitinib in Patients with met-driven Papillary Renal Cell Carcinoma”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2020.2218.

Nature Reviews UrologyJournal

Harnessing Cell-free DNA: Plasma Circulating Tumour DNA for Liquid Biopsy in Genitourinary Cancers

Maia, Manuel Caitano, Meghan Salgia, and Sumanta K. Pal. 2020. “Harnessing Cell-free DNA: Plasma Circulating Tumour DNA for Liquid Biopsy in Genitourinary Cancers”. Nature Reviews Urology. Springer Science and Business Media LLC. doi:10.1038/s41585-020-0297-9.

clinicaltrials.govStudy

Savolitinib vs. Sunitinib in MET-driven PRCC.

2017. "Savolitinib vs. Sunitinib in MET-driven PRCC.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03091192.

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