Savolitinib vs. Sunitinib in MET-driven PRCC.

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Carcinoma, Renal Cell, Kidney Neoplasms, Urologic Neoplasms, Kidney Diseases, Neoplasms by Site, Enzyme Inhibitors, Protein Kinase Inhibitors

In brief

This study is designed for patients diagnosed with MET-driven, unresectable and locally advanced or metastatic Papillary Renal Cell Carcinoma. The purpose of this study is to see if an investigational new anti-cancer medication, savolitinib, is effective in treating patients with MET-driven PRCC, how it compares with another medication frequently used to treat this disease called sunitinib, and what side effects it might cause.

Key facts

Study ID: NCT03091192
Run by: AstraZeneca
People needed: 60
Starts: 2017-07-25
Expected to finish: 2026-12-31
Last updated by the study team: 2026-07-14

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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
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
Adequate haematological, renal, cardiac and liver functions
Karnofsky performance status ≥ 80

You may not qualify if…

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.
Prior treatment with a MET inhibitor (e.g. foretinib, crizotinib, cabozantinib, onartuzumab or previous savolitinib) or sunitinb.
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).
Wide field radiotherapy administered ≤28 days or limited field radiation for palliation ≤7 days prior to the date of randomisation
Major surgical procedures ≤28 days of randomisation or minor surgical procedures ≤7 days. No waiting is required following port-a-cath placement.
Previously untreated brain metastases
Serious active infection or gastrointestinal disease
Presence of other active cancers, or history of treatment for invasive cancer within the last 5 years.
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

Where it is running

Research Site — Atlanta, Georgia, United States
Research Site — Chicago, Illinois, United States
Research Site — Iowa City, Iowa, United States
Research Site — Boston, Massachusetts, United States
Research Site — Kansas City, Missouri, United States
Research Site — New York, New York, United States
Research Site — Nashville, Tennessee, United States
Research Site — Barretos, Brazil
Research Site — Curitiba, Brazil
Research Site — Passo Fundo, Brazil
Research Site — Pelotas, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Porto Alegre, Brazil
Research Site — Rio de Janeiro, Brazil
Research Site — São José do Rio Preto, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Bordeaux, France
Research Site — Vandœuvre-lès-Nancy, France
Research Site — Villejuif, France
Research Site — Arezzo, Italy
Research Site — Meldola, Italy
Research Site — Milan, Italy
Research Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

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