Phase II study of oral PRednisone 5 mg bid plus EVerolimus in patients with metastatic renal cell cancer after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitors (PREV study)

Phase 1

• Conditions: metastatic renal cell cancer; MedDRA version: 20.0Level: LLTClassification code 10050076Term: Metastatic renal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002419-14-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-19
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

-Patients with renal cell carcinoma who failed at least one VEGFR TKI
-Patients with adequate bone marrow function
-Patients with adequate liver function
-Patients with adequate renal function

Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

-CNS disease OR patients with presence or history of central nervous system (CNS) lymphoma
-Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone = 20 mg for adrenal insufficiency). However, patients receiving corticosteroids must be on a stable dose for = 4 weeks prior to the first dose of everolimus. Topical or inhaled corticosteroids are permitted.
-Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
-Patients with uncontrolled hyperlipidemia (= Grade 3 hyperlipidemia despite optimal supportive medical therapy)
-Patients with an active, bleeding diathesis
-Previous organ transplantation
-Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of prednisone 5 mg bid and everolimus 10 mg/day in patients with metastatic renal cell cancer.;Secondary Objective: To evaluate the activity and the clinical outcome of these patients.<br>Exploratory objectives:<br>To evaluate the influence of prednisone on trough concentration of everolimus and correlation with the incidence of side effects, in particular stomatitis and non-infectious pneumonitis. <br>Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS).<br>;Primary end point(s): evaluate the incidence of grade = 2 stomatitis and non-infectious pneumonitis in RCC patients treated with prednisone 5 mg bid and everolimus 10 mg/day.;Timepoint(s) of evaluation of this end point: 3 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate overall response rate, PFS and OS in this patient population. <br>Exploratory Endpoints: To evaluate the influence of prednisone on trough concentration of everolimus and correlation with the incidence of side effects, in particular stomatitis and non-infectious pneumonitis. <br>Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS).<br>;Timepoint(s) of evaluation of this end point: 3 years