Carcinoma metastásico de células renales (Advanced renal cell cancer.) MedDRA version: 9.1 Level: LLT Classification code 10038407 Term: Renal cell cancer
Conditions
Interventions
Trade Name: NEXAVAR
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sorafenib
CAS Number: 28844-1-73-1
Current Sponsor code
Sponsors
Bayer Healthcare AG, Leverkusen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Disease progression as defined by RECIST criteria following documented stable disease or better after at least 8 weeks of sunitinib as first-line treatment (or two cycles of 4 weeks on and 2 weeks off treatment) • And/or patients who have discontinued sunitinib treatment at any point due to toxicity • Study entry at least 2 weeks after treatment with sunitinib but up to a maximum of 8 weeks • MSKCC prognostic score low or intermediate • ECOG Performance Status of 0 or1 • Patient must have histologically confirmed metastatic renal cell carcinoma with predominant clear cell histology (clear cell component more than 50%) • Age > 18 years • Life expectancy of at least 12 weeks • Patients with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic Resonance Imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix 10.5 ) • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: • Hemoglobin > 9.0 g/dl • Absolute neutrophil count (ANC) >1,500/mm3 • Platelet count ? 100,000/µl • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patient should be excluded if they have unresolved chronic toxicity grade > 1 and related to prior therapy with sunitinib. • History of cardiac disease: o Congestive heart failure NYHA (New York Heart Association) class > 2 o Active CAD (Coronary artery disease) or MI (Myocardial Infarction) more than 6 months prior to study entry is allowed) o Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) o Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management. • Known history of HIV (Human immunodeficiency virus) infection or chronic Hepatitis B or C • Active clinically serious infections (grade > 2 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE Version 3.0)) • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics) • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative brain imaging study within 4 weeks of study entry and is clinically stable , with respect to CNS metastases, at the time of study entry. Also the patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies) • History of organ allograft • Patients with evidence or history of bleeding diathesis or coagulopathy • Patients undergoing renal dialysis • Previous or concurrent cancer that is distinct in primary site or histology form the renal cell carcinoma EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invades lamina propria)] or any cancer curatively treated > 3 years prior to study entry • Any hemorrhage/bleeding event grade > 3 within 4 weeks of first dose of study drug • Serious, non-healing wound, ulcer, or bone fracture • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to 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. The investigator is requested to advise the patient how to achieve an adequate contraception. • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results • Known or suspected allergy to the investigational agent or any agent given in association with this trial • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study • Patients unable to swallow oral medications • Any malabsorption condition Excluded therapies and medications, previous and concomitant: • Any anticancer therapy during the study • Radiotherapy during study or within 3 weeks of start of st
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to evaluate if the addition of low doses of IFN alpha-2a to sorafenib would be beneficial, by estimating the median PFS, in patients who have previously either progressed or are intolerant to sunitinib. The primary end-point is the PFS before dose escalation. ;Secondary Objective: Secondary variables include response rate, time to progression, duration of response and overall survival.; Primary end point(s): After progression the dose of sorafenib can be increased in both arms. The primary end-point is the first PFS time which will be described using Kaplan-Meier curves for each treatment group. The median PFS time and the percentage of patients progression-free at 3, 6, and 12 months will be displayed with their 95% confidence intervals for each treatment group. In addition, the Hazard Ratio will be presented with its 95% confidence interval. For the PFS time after dose escalation to 600 mg BID, the medians will be estimated with their 95% confidence interval. | — |
Countries
Austria, France, Ireland, Italy, Poland, Spain, United Kingdom
Outcome results
None listed