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 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) - PREV

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002419-14-IT

Enrollment

Registered

2018-09-19

Start date

2015-09-02

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic renal cell cancer MedDRA version: 20.0 Level: LLT Classification code 10050076 Term: Metastatic renal carcinoma System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: EVEROLIMUS Current Sponsor code: EVEROLIMUS_IRSTIRCCS Other descriptive name: EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. Exploratory objectives: 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. Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS). ;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	—

Measure

Time frame

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. Exploratory objectives: 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. Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS). ;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

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate overall response rate, PFS and OS in this patient population. 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. Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS). ;Timepoint(s) of evaluation of this end point: 3 years	—

Measure

Time frame

Secondary end point(s): To evaluate overall response rate, PFS and OS in this patient population. 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. Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-ß and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS). ;Timepoint(s) of evaluation of this end point: 3 years

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Countries

Italy

Contacts

Public ContactCentro di Coordinamento Studi IRST

IRST IRCCS

cc.ubsc@irst.emr.it+39 0544 285813

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026