Savolitinib vs. Sunitinib in MET-driven PRCC.
A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)
2 other identifiers
interventional
60
7 countries
59
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2017
Longer than P75 for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
March 27, 2017
CompletedStudy Start
First participant enrolled
July 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2019
CompletedResults Posted
Study results publicly available
July 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 14, 2026
April 1, 2026
2.1 years
February 9, 2017
June 22, 2020
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)
Per Response Evaluation Criteria in Solid Tumours (RECIST v1.1) assessed by MRI or CT: Progressive Disease (PD): \>= 20% increase in the sum of diameters of TLs and an absolute increase in sum of diameters of \>=5mm (compared to the previous minimum sum) or progression of NTLs or a new lesion. PFS is the time from date of randomisation until the date of PD (defined by Recist 1.1 and confirmed by BICR) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Secondary Outcomes (5)
Overall Survival (OS)
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Objective Response Rate (ORR) by BICR
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Duration of Response (DoR) by BICR
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 6 Months by BICR
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Disease Control Rate (DCR) at 12 Months by BICR
RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by BICR.
Study Arms (2)
Savolitinib
EXPERIMENTALSee: intervention description
Sunitinib
ACTIVE COMPARATORSee: intervention description
Interventions
600 mg (400 mg if \<50 kg) by mouth (PO) with a meal once daily (QD), continuously
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Hutchison Medipharma Limitedcollaborator
Study Sites (59)
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, 120-752, South Korea
Research Site
Seoul, 6351, 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
Related Publications (2)
Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
PMID: 32469384DERIVEDMaia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
PMID: 32203306DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Study Officials
- PRINCIPAL INVESTIGATOR
Toni K Choueiri, MD
Dana-Farber Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
March 27, 2017
Study Start
July 25, 2017
Primary Completion
August 18, 2019
Study Completion (Estimated)
December 31, 2026
Last Updated
April 14, 2026
Results First Posted
July 10, 2020
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.