MedDRA version: 16.1 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: Nexavar
Product Name: Nexavar
Product Code: L01XE05
Pharmaceutical Form: Tablet
Sponsors
Fondazione IRCCS Istituto Nazionale dei Tumori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Patients with hystological diagnosis of Renal Cell Carcinoma (RCC) • Measurable disease • ECOG Performance Status of 0 or 1 • Life expectancy of at least 12 weeks. • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: - Hemoglobin ? 10.0 g/dl - Absolute neutrophil count (ANC) >1,500/mm3 - Platelet count ? 100,000/ml - Total bilirubin = 1.5 times the upper limit of normal - ALT and AST = 2.5 x upper limit of normal - Alkaline phosphatase = 4 x ULN - PT-INR/PTT = 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care. • Prognosis according to Heng: good or intermediate • Previous treatment with pazopanib • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and two weeks after the completion of trial. • Signed informed consent must be obtained prior to any study specific procedures 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 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • First line treatment for metastatic RCC other than pazopanib. • History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension (>= 160 mmHg systolic and/or 90 mmHg diastolic). • History of HIV infection • Active clinically serious infections (> grade 2 NCI-CTC version 3.0) • Brain or meningeal metastases • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) • History of organ allograft • Patients with evidence or history of bleeding diasthesis • Patients undergoing renal dialisis • 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 • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of sorafenib (PFS) as second line of treatment in patients treated with pazopanib for mRCC.;Secondary Objective: • To evaluate the safety of sorafenib in patients previously treated with pazopanib • To evaluate the Overall Survival • To evaluate the Quality of Life through specific questionnaires (FKSI-19; EORTC QLQ-C30). ;Primary end point(s): To evaluate the efficacy of sorafenib (PFS) as second line of treatment in patients treated with pazopanib for mRCC.;Timepoint(s) of evaluation of this end point: 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): safety, Overall survival and quality of life;Timepoint(s) of evaluation of this end point: 18 months | — |
Countries
Italy
Contacts
Public Contacttrialcenter
Fondazione IRCCS Istituto Nazionale dei tumori
Outcome results
None listed