ADVANCED RENAL CELL CANCER MedDRA version: 9.1 Level: LLT Classification code 10050513 Term: Metastatic renal cell carcinoma
Conditions
Interventions
Product Name: sorafenib
Pharmaceutical Form: Modified-release capsule, hard
INN or Proposed INN: Sorafenib
Current Sponsor code: Bay 43-9006
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
I.T.M.O. - ITALIAN TRIALS IN MEDICAL ONCOLOGY
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed written informed consent (approved by institutional review board / independent ethics committee) 2.Patient must be willing and able to comply with the protocol 3.Age >= 18 years 4.Patients with cito-hystological diagnosis of renal cell carcinoma (RCC) 5.If the initial diagnosis of RCC is dated more than two years ago,cito- histological confirmation of renal cell carcinoma origin of the current lesions is mandatory 6.Fertile women (/= 60% 9.Life expectancy greater than 3 months 10.The required values at baseline are as follows: Absolute neutrophil count >1.5 x 109 /L, Platelet count > 100 x 109 /L, Haemoglobin > 9g/dl, total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Prior medical treatment for metastatic RCC (are allowed adjuvant or neo-adjuvant treatment but stopped almost from six months) 2.Major surgical procedure within 28 days prior to study treatment start 3.Evidence of current central nervous system (CNS) metastases or spinal cord compression. Patients must undergo a MRI or CT scan of the brain within 28 days prior to randomisation 4.Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, meningiomas) 5.Clinically significant cardiovascular disease, for example cerebrovascular accidents (10 mg/day methylprednisolone equivalent) excluding inhaled steroids. 8.History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates use of an investigational drug or patient at high risk from treatment complications 9.Prior isotope treatment 10.PT or INR and PTT = 160 mmHg systolic and/or 90 mmHg diastolic) while receiving chronic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival;Secondary Objective: 1. To determine the overall survival, objective response rates of Sorafenib and Interleukin 2 as compared with Sorafenib alone 2. To characterize the safety profile of the combination therapy versus Sorafenib alone;Primary end point(s): To evaluate the efficacy of the combination of Sorafenib and Interleukin 2 compared with Sorafenib alone in patients with metastatic renal cell carcinoma based on progression free survival | — |
Countries
Italy
Outcome results
None listed