NCT02338570

Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus (ORCHIDEE)

Outcome-related Factors in Patients With Metastatic Renal Cell Carcinoma Treated With Everolimus After Failure of a First-line Treatment With VEGF Inhibitor

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of unfavourable outcome-related factors in patients affected by renal cell cancer in treatment with everolimus and previously treated with a Vascular endothelial growth factor (VEGF) inhibitor (i.e. sunitinib, sorafenib,pazopanib, or bevacizumab+interferon)

Detailed description

Predictive factors to be considered are: histology, Heng risk group, Eastern Cooperative Oncology Group-performance status (ECOG-PS), site of metastases, glycemia and cholesterolemia. The data collected in this "real life" population could contribute to identify clinical factors that predict favourable outcomes in patients treated with everolimus after failure or a a first-line treatment with a VEGF inhibitor.

Conditions

• Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Everolimus	Patients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets).

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2015-01-14
• Last updated: 2018-02-05

Locations

8 sites across 1 country: Italy