Trials / Active Not Recruiting
Active Not RecruitingNCT03091192
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)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 130 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Urologic Neoplasms
- Kidney Diseases
- Neoplasms by Site
- Enzyme Inhibitors
- Protein Kinase Inhibitors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Savolitinib | 600 mg (400 mg if \<50 kg) by mouth (PO) with a meal once daily (QD), continuously |
| DRUG | Sunitinib | 50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off |
Timeline
- Start date
- 2017-07-25
- Primary completion
- 2019-08-18
- Completion
- 2026-12-31
- First posted
- 2017-03-27
- Last updated
- 2026-04-14
- Results posted
- 2020-07-10
Locations
59 sites across 7 countries: United States, Brazil, France, Italy, Russia, South Korea, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03091192. Inclusion in this directory is not an endorsement.