metastatic renal cell carcinoma, second line therapy after failure of one VEGF-TKI targeted therapy MedDRA version: 19.0 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
iOMEDICO AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet the following criteria to be enrolled: 1. Provide written informed consent 2. Aged 18 years and above 3. Histologically or cytologically confirmed predominantly clear cell renal cell carcinoma 4. Metastatic disease documented by CT or MRI (histological confirmation not mandatory but wishful) 5. Patients with or without nephrectomy (partial or total) 6. Patients with at least one measurable lesion at baseline according to RECIST criteria 1.1 7. Failure of exactly one prior VEGFR-TKI therapy (e.g. sunitinib, sorafenib, pazopanib) for metastatic renal cell carcinoma 8. ECOG 0-2 9. Hemoglobin = 9.0 g/dL 10. Platelet count =75,000/µL 11. Absolute neutrophil count =1,5x109/l 12. Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Patients who have received >1 prior VEGFR-TKI therapy or prior therapy with bevacizumab +/- interferon. 2. VEGFR-TKI therapy within 14 days prior to start of study drug 3. Patients who have previously received systemic mTOR inhibitors (sirolimus, temsirolimus, everolimus). 4. Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients. 5. Any condition which, in the opinion of the investigator, would preclude participation in this trial 6. Patients within 4 weeks post-major surgery (e.g., intra-thoracic, intra-abdominal or intrapelvic), open biopsy, or significant traumatic injury to avoid wound healing complications. Minor procedures and percutaneous biopsies or placement of vascular access device require 7 days prior to study entry. 7. Patients who had radiation therapy as part of the curative treatment within 4 weeks prior to start of study treatment. Palliative radiotherapy to bone lesions within 2 weeks prior to study treatment start. 8. Patients in anticipation of the need for major surgical procedure during the course of the study. 9. Patients with a serious non-healing wound, ulcer, or bone fracture. 10. Patients with a history of seizure(s) not controlled with standard medical therapy. 11. History or clinical evidence of central nervous system (CNS) metastases. Subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and meet all 3 of the following criteria are eligible: a) are asymptomatic and, b) have had no evidence of active CNS metastases for = 3 months prior to enrolment (inactive/controlled CNS metastases are allowed) and, c) have no requirement for steroids or enzyme-inducing anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin) 12. Patients receiving chronic systemic treatment with corticosteroids (dose of > 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable. 13. Poorly controlled diabetes as defined by fasting serum glucose >2.0 x ULN. 14. Active (acute or chronic) or uncontrolled infection of bacterial, mycotic or viral genesis. 15. Liver disease such as chronic active hepatitis or chronic persistent hepatitis. 16. Impaired liver function classified as Child-Pugh class C. 17. Patients with a known history of HIV seropositivity. 18. Patients with active bleeding disorders. 19. Patients who have any severe and/or uncontrolled medical conditions or other conditions within the past 12 months that could affect their participation in the study or any disorders that impair the ability to evaluate the patient or for the patient to complete the study according to the investigators assessment. 20. Patients who have a history of another primary malignancy and off treatment for = 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix or breast, and localized cancer of the bladder (T1) and prostate (T1 - T2). 21. Female patients who are pregnant or breast feeding. 22. Men and women of reproductive potential who are not using highly effective birth control methods. Oral contraceptives for female patients and barrier contraceptives are not acceptable. For definition of highly effective birth control methods please refer to section 12.3.6 of this protocol. 23. Patients who are using other investigational agents or w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to assess the rate of patients who are free of disease progression after 6 months of treatment with everolimus.;Secondary Objective: The secondary objectives of this study are: - Estimate the progression free survival of patients treated with everolimus after having progressed on or after one VEGF-targeted therapy - To assess overall survival of patients treated with everolimus after failure of one VEGF-targeted therapy. - To assess the overall response rate (ORR) according to RECIST-criteria and the duration of response - To assess the safety profile of everolimus after failure of one VEGF-targeted therapy ;Primary end point(s): - Rate of patients progression free 6 months after start of study treatment. ;Timepoint(s) of evaluation of this end point: 8 month after accrual of the last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Progression free survival, - Overall survival - Objective response rate - Incidence of adverse events, serious adverse events, incidence of laboratory abnormalities (hematology, blood chemistry and urinalysis ;Timepoint(s) of evaluation of this end point: End of Study (at latest September 2017) | — |
Countries
Germany
Contacts
Public ContactProject Leader
iOMEDICO
Outcome results
None listed