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)
Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) — RECIST tumour assessments every 6 weeks from randomisation until disease progression as defined by Recist 1.1 and confirmed by 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.
Trial sites (59)
Facility
City
Region
Status
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.
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.