metastatic hormone-refractory prostate cancer MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Trade Name: Nexavar
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sorafenib
CAS Number: 284461-73-0
Current Sponsor code: BAY 43-9006
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Austrian Prostate Study Group (AUPSG)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1 Age = 18 years 2 Histologically / cytologically proven adenocarcinoma of the prostate 3 Metastatic disease with documented clinical (imaging) progression of an existing lesion (RECIST), appearance of a new lesion, or bone scan showing new skeletal lesions following docetaxel application. Biochemical (PSA) progression alone is not sufficient to document progression. 4 One prior chemotherapy with a total dose of 450 mg/m2 docetaxel. 5 Prior surgery and/or radiation therapy (to less or equal than 25% of the bone marrow only) are allowed. At least 4 weeks must have elapsed since the completion of surgery/radiation therapy and the patient must have recovered from side-effects. 6 Disease progression after prior hormonal therapy and subsequent cytotoxic chemotherapy with a total dose of 450mg/m2 docetaxel 7 Patients should have progressive disease defined as PSA progression documented by 2 consecutive rises in PSA values over a previous reference value taken at least one week apart or measurable disease progression according to the modRECIST criteria. 8 PSA at time of study entry = 5 ng/ml within 1 week prior to randomization. 9 Castrate level of testosterone (? 0.5 ng/ml). Patients with medical castration with LH-RH analogue must continue LH-RH analogue. 10 Anti-androgen treatment with Flutamide, Bicalutamide or Nilutamide should be withdrawn at least 6 weeks prior to the start of chemotherapy. 11 Continuation of bisphosphonates allowed. 12 ECOG PF 0-2 13 Life expectancy > 12 weeks 14 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: 1 Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry. 2 History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 mo prior to study entry is allowed); cardiac arrythmias requiring anti-arrythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 3 History of HIV infection or chronic hepatitis B or C 4 Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 5 Clinically symptomatic brain or meningeal metastasis 6 Patients with seizure disorder requiring medication (such as anti-epileptics) 7 Evidence of painful and/or destructive bone metastases for which radiation therapy, initiation of bisphosphonates or bone-seeking radionucleides are considered necessary by the treating physician. Other bone metastases are allowed. 8 History of organ allograft 9 Patients with evidence or history of bleeding diasthesis 10 Patients undergoing renal dialysis 11 More than 1 prior anticancer chemotherapy or immunotherapy during or within 4 weeks of the study entry 12 Prior isotope therapy (e.g. strontium, samarium) 13 Radiotherapy during study or within 3 weeks of start of study drug 14 Major surgery within 4 weeks of start of study 15 Autologous bone marrow transplant or stem cell rescue within 4 months of study 16 Investigational drug therapy outside of this trial during or within 4 weeks of study entry 17 Prior exposure to the study drug or licensed angiogenesis-inhibitors. 18 Prior use of inhibitors of Ras/Raf-, MEK, AKT kinase and mTOR-signaling pathway or farnesyl transferase inhibitors 19 Concomitant treatment with ketoconazole, itraconazole, ritonavir, rifampicin. 20 Childbearing potential: men 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. 21 Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results 22 Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study 23 Patients unable to swallow oral medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the 12-week stabilization rate of sorafenib or placebo after docetaxel failur in patients with hormone-refractory prostate cancer.;Secondary Objective: To assess the response rate according to RECIST criteria To assess progression free survival To evaluate quality of life (QLQ-C30) To measure markers of the in vivo anti-tumor efficacy and mechanisms of action (optional) To measure cell signaling and tumor cell death in biopsies (optional);Primary end point(s): The stabilizazion of hormone-refractory prostate cancer in patients with docetaxol failure after 12 week treatment with sorafenib or placebo and best supportive care. | — |
Countries
Austria
Outcome results
None listed