Savolitinib vs. Sunitinib in MET-driven PRCC.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
More AstraZeneca trials in Italy
Other trials for the same condition
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 Italy