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

Conditions: metastatic renal cell carcinoma in progression after a first line treatment with a VEGF inhibitor.
MedDRA version: 17.1Level: PTClassification code 10067946Term: Renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-002508-26-IT

Lead Sponsor: IRCCS - Istituto di Ricerche Farmacologiche Mario Negri

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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 <2;
3.With target and/or non-target lesions according to RECIST 1.1;
4.Following failure of a previous treatment with VEGF-targeted therapy (e.g. sunitinib, sorafenib, pazopanib, or bevacizumab+interferon);
5.For whom a decision has been taken to initiate everolimus treatment or patient currently receiving treatment with everolimus by a period of time =30 days;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 170

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;