metastatic renal cell carcinoma in progression after a first line treatment with a VEGF inhibitor. MedDRA version: 17.1 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Afinitor
Product Name: everolimus
Pharmaceutical Form: Tablet
INN or Proposed INN: Afinitor
CAS Number: 159351-69-6
Other descriptive name: EVEROLIMUS
Concentration unit: mg milligram(s)
C
Sponsors
IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older, with histologically or cytologically confirmed mRCC (clear cell or not clear cell); 2. ECOG-PS =65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
Exclusion criteria: 1. Previous treatment with everolimus or at the date of written informed consent provision receiving everolimus by more than 30 days; 2. Symptomatic central nervous system metastases. Patients may be eligible if the central nervous system metastases have been adequately treated (surgery or radiotherapy), and do not require ongoing corticosteroids for control of symptoms and have had no evidence of progression for at least three months; 3. Treatment with an investigational agent in the past 4 weeks; 4. Any of the following in the last year: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack or pulmonary embolism; 5. Ongoing grade =2 cardiac dysrhythmias, atrial fibrillation of any grade or prolongation of the corrected QT interval to >450 msec for males or >470 msec for females; 6. Pregnancy (negative pregnancy test required for women of child-bearing potential), breast feeding;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify factors predictive of a favourable outcome, in terms of survival free from an unfavourable event, in patients treated with everolimus as second line treatment for metastatic renal cell carcinoma (mRCC) after failure of a first-line treatment with a vascular endothelial growth factor (VEGF) inhibitor.;Secondary Objective: To evaluate: • efficacy in terms of progression free survival of everolimus as second line treatment; • health related quality of life (HRQoL), as measured by the EQ-5D questionnaire; • drug-related toxicity, assessed by the National Cancer Institute-Common Terminology Criteria for adverse events (NCI-CTCAE), version 4.03; • treatment compliance. ;Primary end point(s): Survival free from an unfavourable event, calculated in each patient as the time from the date of written informed consent provision to the date of occurrence of the first among the following events: death from any cause, disease progression (according to RECIST 1.1), interruption of everolimus due to toxicity and/or deterioration of clinical conditions, and HRQoL deterioration (7-point decrease from baseline evaluation on the EQ-5D visual analogue scale).;Timepoint(s) of evaluation of this end point: At the end of the study, i.e. when the target number of events is reached and the last patient enrolled events is reached and the last patient, is followed for at least 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression free survival, calculated in each patient as the time from the date of written informed consent provision to the date of first progression or death from any cause, whichever comes first; • EQ-5D questionnaire score; • Treatment compliance; • Maximum toxicity grade experienced by each patient for each specific toxicity, giving the frequency of patients experiencing adverse events that are recorded as grade 3-5 (also grade 2 for neurotoxicity); • Type and frequency of serious adverse reactions. ;Timepoint(s) of evaluation of this end point: At the end of the study, i.e. when the target number of events is reached and the last patient enrolled events is reached and the last patient, is followed for at least 12 months | — |
Countries
Italy
Contacts
Public ContactClinical Research laboratory
IRCCS - Istituto di Ricerche Faramcologiche "Mario Negri"
Outcome results
None listed