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Clinical Trials in the USA / NCT03091192
Active, not recruiting Phase 3

Savolitinib vs. Sunitinib in MET-driven PRCC.

NCT03091192 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2017-07-25
Last updated
2026-07-14

Condition(s) studied

CarcinomaCarcinoma, Renal CellKidney NeoplasmsUrologic NeoplasmsKidney DiseasesNeoplasms by SiteEnzyme InhibitorsProtein Kinase Inhibitors

Investigational drug(s) / intervention(s)

SavolitinibSunitinib

Savolitinib: 600 mg (400 mg if \<50 kg) by mouth (PO) with a meal once daily (QD), continuously

Sunitinib: 50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Research Site La Jolla California
Research Site Atlanta Georgia
Research Site Chicago Illinois
Research Site Iowa City Iowa
Research Site Boston Massachusetts
Research Site Kansas City Missouri
Research Site New York New York
Research Site Nashville Tennessee
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 Modena Italy
Research Site Orbassano Italy
Research Site Pavia Italy
Research Site Roma Italy
Research Site Krasnoyarsk Russia
Research Site Moscow Russia
Research Site Moscow Russia
Research Site Moscow Russia
Research Site Moscow Russia
Research Site Murmansk Russia
Research Site Nizhny Novgorod Russia
Research Site Obninsk Russia
Research Site Omsk Russia
Research Site Saint Petersburg Russia
Research Site Saint Petersburg Russia

+ 19 more sites — see the full list on the official registry below.

More AstraZeneca trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03091192 on ClinicalTrials.gov ↗ ← All trials in the USA