Advanced / metastatic renal cell carcinoma MedDRA version: 19.1 Level: PT Classification code 10038410 Term: Renal cell carcinoma recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10050513 Term: Metastatic renal cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Nexavar
Product Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SORAFENIB TOSILATE
CAS Number: 475207-59-1
Other descriptive name: Sorafenib
Concentration unit:
Sponsors
Fakultät für Medizin der Technischen Universität München
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with metastatic / advanced RCC (all histologies), who are not suitable for cytokine therapy and for whom study medication constitutes first-line treatment. For cytokine-unsuitability at least one of the following criteria must be fulfilled*: - Age 66 to 88 years - Non-clear cell histology RCC - Intermediate risk according to MSKCC score - ECOG = 1 and> 1 organ metastasis + 9.0 g/dl - Absolute neutrophil count (ANC) >1,500/µl - Platelet count 100,000/µl - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 377
Exclusion criteria
Exclusion criteria: Excluded medical conditions: 1. History of cardiac disease: congestive heart failure >NYHA class 2 or with LVEF at baseline echocardiography grade 2 NCI-CTC version 4.03) 5. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry) 6. Patients with seizure disorder requiring medication (such as steroids or antiepileptics) 7. Patients with evidence or history of bleeding diathesis 8. History of organ allograft 9. Major surgery within 4 weeks of start of study 10. Autologous bone marrow transplant or stem cell rescue within 4 months before study start. 11. Any significant condition that increases the risk for bleeding, including, but not limited to active peptic ulcer disease, inflammatory bowel disease, known intraluminal or endobronchial metastatic lesions and/or lesions infiltrating major pulmonary vessels with risk of bleeding, presence of non-healing wound or trauma within 4 weeks prior to first dose of investigational drug 12. History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT) within the past 6 months (Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible) 13. Corrected QT Interval (QTc) > 480 msecs 14. Untreated hypothyroidism 15. Patients undergoing renal dialysis 16. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this studyn 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 17. 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 (with a Pearl Index < 1) during the course of the trial and 3 months after the completion of trial. 18. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results 19. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 20. Patients unable to swallow oral medications 21. Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product 22. Known allergy to Votrient® or Nexavar®(i.e. to active substance or one of the constituents) 23. Prior exposure to study drugs. 24. Investigational drug therapy within 4 weeks of study entry. 25. Use of biologic response modifiers, such as G-CSF and other hematopoietic growth factors, within 3 weeks of study entry 26. Radiotherapy within 3 weeks of start of study drug and planned radiotherapy during the study 27. Concomitant medication: Any cond
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if progression -free survival from randomization to progression or death during second -line therapy (total PFS) of sorafenib followed by pazopanib ist non-inferior compared to pazopanib followed by sorafenib;Secondary Objective: 1. Time from randomization to progression during second-line therapy (total TTP) 2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm. 3. PFS in first-line and second-line treatment, descriptively 4. Overall survival, descriptively (data cut-off same as for primary endpoint) 5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria) 6. Health-related Quality of Life (FACT-F, FKSI-10) 7. Safety and tolerability;Primary end point(s): To evaluate if progression -free survival from randomization to progression or death during second -line therapy (total PFS) of sorafenib followed by pazopanib ist non-inferior compared to pazopanib followed by sorafenib;Timepoint(s) of evaluation of this end point: No interim analyses are planned. The final analyses will take place once all patients have terminated trial therapy. This is planned for Q4 2016. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time from randomization to progression during second-line therapy (total TTP) 2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm. 3. PFS in first-line and second-line treatment, descriptively 4. Overall survival, descriptively (data cut-off same as for primary endpoint) 5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria) 6. Health-related Quality of Life (FACT-F, FKSI-10) 7. Safety and tolerability;Timepoint(s) of evaluation of this end point: No interim analyses are planned. The final analyses will take place once all patients have terminated trial therapy. This is planned for Q4 2016. | — |
Countries
Austria, Germany, Netherlands
Contacts
Public ContactClinical Research Organisation
iOMEDICO AG
Outcome results
None listed