Metastatic renal cells carcinoma MedDRA version: 11.0 Level: HLT Classification code 10038408 Term: Renal cell carcinomas System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Product Code: L01XE05
Pharmaceutical Form: Tablet
INN or Proposed INN: SORAFENIB
CAS Number: 284461-73-0
Concentration unit: mg milligram(s)
Concentration t
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 • Previous treatment with two sequences of TKIs including sunitinib followed by axitinib and pazopanib followed by sorafenib. • ECOG Performance Status of 0 or 1 • All prognostic group according to Heng criteria • 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. • 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 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: • Previous treatment for metastatic RCC other than pazopanib followed by sorafenib or sunitinib followed by axitinib • 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) • 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 findings or clinical laboratory findings 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 > 2 years prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a third TKI after two previous lines of therapy with TKIs, in terms of mPFS;Secondary Objective: • To evaluate the safety of a third line with TKI • To evaluate the Overall Survival • To evaluate the Quality of Life through specific questionnaires (FKSI-19; EORTC QLQ-C30). ;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: every 8 weeks (+/- 7 days) for the first six months and then every 12 weeks (+/- 7 days) until PD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To evaluate the safety of a third line with TKI • To evaluate the Overall Survival • To evaluate the Quality of Life through specific questionnaires (FKSI-19; EORTC QLQ-C30). ;Timepoint(s) of evaluation of this end point: safety and QoL: every month OS: until death of patient | — |
Countries
Italy
Contacts
Public ContactTrial center
Trial center
Outcome results
None listed