EUCTR2007-004396-19-IT进行中（未招募）不适用
Phase II, open label, non-randomized study of second or third line treatment with sorafenib (BAY 43-9006) in patients affected by relapsed high-grade osteosarcoma. - HGosteo-BAY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients with histologically documented and not surgically resectable or metastatic high-grade osteosarcoma which progressed after first or second line treatments for relapsing disease. 2) Measurable disease as defined by having at least one lesion that can be accurately measured by means of CT or MRI. Baseline evaluations must be completed within 2 weeks prior to enrollment. 3) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 and an estimated life expectancy of at least 3 months. Patients with and ECOG P.S. 2 are eligible if the P.S.2 depends solely on orthopedic problems. 4)Age >/= 15 years. 5)Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of treatment: -Hemoglobin > 9.0 g/dl; -Absolute neutrophil count (ANC)>1,500/mm3. -Platelet count >/=100,000/μl. -Total bilirubin <1.5 times the ULN; -ALT and AST<2.5 x ULN(< 5 x ULN for patients with liver involvement of their cancer); -PT-INR/PTT <1.5xULN [Patients who are being therapeutically anticoagulated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] -Serum creatinine < 1.5 x ULN. - Written informed consent
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 2)Coexisting malignancies, except for basal or epithelial cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥3 years. 3)History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension. 4)History of HIV infection or chronic hepatitis B or C. 5)Active clinically serious infections (> grade 2 NCI-CTC version 3.0) 6)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) 7)Patients with seizure disorders requiring medication (such as steroids or anti-epileptics) 8)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. 9)Patients with evidence or history of bleeding diathesis. 10)Patients undergoing renal dialysis
研究者
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