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New hope for rare kidney cancer: targeted drug savolitinib faces off against standard therapy

NCT ID NCT03091192

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This phase 3 study compares a new drug, savolitinib, to the standard drug sunitinib in 60 people with a specific type of advanced kidney cancer called MET-driven papillary renal cell carcinoma. The goal is to see if savolitinib is better at stopping the cancer from growing and to check its side effects. Participants take one of the two pills by mouth daily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
savolitinib
What this could lead to
If it works, this could provide a more effective treatment option for people with a specific type of kidney cancer that has spread.
What could go wrong
This is a phase 3 trial, but it's small (60 people) and results may not apply to all patients. Savolitinib may not prove better than sunitinib and could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

60 people

The number who actually took part.

Started

Jul 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed PRCC, which is unresectable/locally advanced or metastatic with measurable disease as per RECIST 1.1. Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney are not considered PRCC and are not eligible. 2. Confirmation of MET-driven PRCC without co-occurring FH or VHL mutations from an FFPE tumour sample using the sponsor-designated central laboratory validated NGS assay 3. Patients who have received no prior systemic therapy as well as those who have received prior systemic therapy for PRCC in the advanced setting.\* Patients can be treatment-naïve, or previously treated, but cannot have previously received sunitinib or a MET inhibitor. Patients who have received prior systemic therapy must have had disease progression in soft tissue disease or bone within 6 months of the last dose of the most recent systemic therapy 4. Adequate haematological, renal, cardiac and liver functions 5. Karnofsky performance status ≥ 80 Exclusion Criteria: 1. Most recent cytotoxic chemotherapy, immunotherapy, chemo-immunotherapy, or investigational agents \<28 days from the date of randomisation. Most recent non cytotoxic targeted therapy \<14 days from the date of randomisation. 2. Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb. 3. Treatment with strong inducers or inhibitors of CYP3A4 or strong inhibitors of CYP1A2, taken within 2 weeks or not possible to be stopped for at least 2 week before the date of randomisation. Herbal medications cannot be taken within 7 days of the date of randomisation (3 weeks for St John's wort). 4. Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation 5. Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement. 6. Previously untreated brain metastases 7. Serious active infection or gastrointestinal disease 8. Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years. 9. Mean resting QTcF \>470 msec for women and \>450 msec for men on the Part 2 screening triplicate ECGs or factors that may increase the risk of QTcF prolongation such as chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes

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Conditions

The condition(s) this trial relates to.

benign urinary system neoplasm carcinoma kidney cancer kidney disorder kidney neoplasm Neoplasms by Site papillary renal cell carcinoma renal cell adenocarcinoma renal cell carcinoma urinary system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carcinoma Carcinoma, renal cell Enzyme inhibitors Kidney diseases Kidney neoplasms Neoplasms by site Protein kinase inhibitors Urologic neoplasms

Contacts and locations

Locations

  • Research Site

    La Jolla, California, 92093, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Chicago, Illinois, 60637, United States

  • Research Site

    Iowa City, Iowa, 52242, United States

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    Kansas City, Missouri, 64132, United States

  • Research Site

    New York, New York, 10021, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Curitiba, 81520-060, Brazil

  • Research Site

    Passo Fundo, 99010-080, Brazil

  • Research Site

    Pelotas, 096015-280, Brazil

  • Research Site

    Porto Alegre, 90050-170, Brazil

  • Research Site

    Porto Alegre, 90610-000, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Rio de Janeiro, 22793-080, Brazil

  • Research Site

    São José do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 01323-903, Brazil

  • Research Site

    Bordeaux, 33000, France

  • Research Site

    Vandœuvre-lès-Nancy, 54519, France

  • Research Site

    Villejuif, 94805, France

  • Research Site

    Arezzo, 52100, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20133, Italy

  • Research Site

    Modena, 41100, Italy

  • Research Site

    Orbassano, 10043, Italy

  • Research Site

    Pavia, 27100, Italy

  • Research Site

    Roma, 00152, Italy

  • Research Site

    Krasnoyarsk, 660133, Russia

  • Research Site

    Moscow, 105077, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 115522, Russia

  • Research Site

    Moscow, RU-121356, Russia

  • Research Site

    Murmansk, 183047, Russia

  • Research Site

    Nizhny Novgorod, 603109, Russia

  • Research Site

    Obninsk, 249036, Russia

  • Research Site

    Omsk, 644013, Russia

  • Research Site

    Saint Petersburg, 194017, Russia

  • Research Site

    Saint Petersburg, 195271, Russia

  • Research Site

    Saint Petersburg, 196603, Russia

  • Research Site

    Volgograd, 400138, Russia

  • Research Site

    Daejeon, 35015, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Hwasun-gun, 58128, South Korea

  • Research Site

    Incheon, 21565, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06273, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    Seoul, 120-752, South Korea

  • Research Site

    Dnipro, 49005, Ukraine

  • Research Site

    Dnipro, 49102, Ukraine

  • Research Site

    Ivano-Frankivsk, 76018, Ukraine

  • Research Site

    Kharkiv Region, 61070, Ukraine

  • Research Site

    Kyiv, 03022, Ukraine

  • Research Site

    Kyiv, 03115, Ukraine

  • Research Site

    Odesa, 65055, Ukraine

  • Research Site

    Sumy, 40022, Ukraine

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