Patients who have metastatic papillary cancer of the kidney and have not received prior systemic treatment for their metastatic RCC. This multicenter international trial will enroll a maximum of 60 patients over a period of approximately 12 months. MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: RAD001 2.5mg Tablets (elongated)
Product Code: RAD0001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Num
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years old • Patients with histological diagnosis of metastatic papillary renal cell carcinoma, type I or II, centrally confirmed (relevant slides (and blocks if available) must be sent for central reading within one month from enrollment: if this is not feasible the patient cannot be considered eligible) • Patients with at least one measurable lesion at baseline as per RECIST criteria • Patients with an ECOG performance status of = 1 • Adequate bone marrow function as shown by: ANC = 1.5 x 109/L, Platelets = 100 x 109/L, Hb >9 g/dL. • Adequate liver function as shown by: serum bilirubin: = 1.5 x ULN, INR=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who had radiation therapy within 28 days prior to start of study treatment (palliative radiotherapy to bone lesions allowed within 2 weeks prior to study treatment start). • Patients who have received any prior systemic treatment for their metastatic RCC, such as sunitinib, sorafenib, and bevacizumab. • Patients who have previously received mTOR inhibitors (sirolimus, temsirolimus, everolimus). • Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients. • Patients with uncontrolled central nervous system (CNS) metastases. • Patients receiving chronic systemic treatment with corticosteroids (dose of = 10 mg/day methylprednisone equivalent) or another immunosuppressive agent. Inhaled and topical steroids are acceptable, as well as opotherapy after bilateral adrenal gland removal. • Patients with a known history of HIV seropositivity. • Patients with autoimmune hepatitis. • Patients with an active, bleeding diathesis. • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study • 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. • Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable. • Patients who are using other investigational agents or who had received investigational drugs = 4 weeks prior to study treatment start. • Patients unwilling or unable to comply with the protocol. • Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A (Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itroconazole, Voriconazole, Ritinavir, Telithromycin) within the last 5 days prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of everolimus as monotherapy for the treatment of papillary renal cancer. Efficacy is defined as the percentage of patients progression-free at 6 months.;Secondary Objective: To evaluate the response rate, duration of response, disease control rate, median progression free survival and overall survival in this patient population, and to further characterize the safety profile of everolimus.;Primary end point(s): Percentage of patients progression-free at month 6 | — |
Countries
Belgium, France, Germany, Italy, Spain, United Kingdom
Outcome results
None listed