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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
Must not have
Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days
Previously untreated brain metastases
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
No Placebo-Only Group
Pivotal Trial

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.
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.
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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had major surgery in the last 4 weeks or minor surgery in the last week.
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My brain cancer has not been treated yet.
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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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I have been treated with a MET inhibitor or sunitinib before.
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I do not have any serious infections or stomach/intestine diseases.

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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Secondary study objectives
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%
Hand-foot syndrome
13%
Liver failure
10%
Abdominal pain
8%
Fever
8%
Increase GGT
8%
Anorexia
5%
Encephalopathy
5%
Phosphatases alcalines
5%
Arterial hypertension
5%
Liver pain
5%
Ascite
5%
Diarrhea
5%
Encephalopathia
5%
Hemoglobine
3%
Hemoglobin
3%
Lumbar pain
3%
Prothrombin time
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sunitinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2024
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,551 Total Patients Enrolled
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
Kidney Disease Research Study Groups: Savolitinib, Sunitinib
Kidney Disease 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
~7 spots leftby Dec 2025
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