ISRCTN49989464已完成4 期
Investigation of the intratumoural concentration and activity of sorafenib in cutaneous schwannomas
Plymouth Hospitals NHS Trust (UK)0 个研究点目标入组 14 人开始时间: 2012年2月14日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Written informed consent
- •2. Diagnosis of NF2
- •3. Over 18 years in age
- •4. Presence of more at least two cutaneous schwannomas >1cm3 in area and accessible for biopsy
- •5. WHO/ECOG Performance Status 0 or 1
- •6. Adequate bone marrow function within 28 days prior to the baseline visit and:
- •6.1. WBC > 3.4x109/l
- •6.2. Platelets > 99x109/l
- •7. Adequate renal function within 28 days prior to the baseline visit
- •7.1. creatinine < 2.5 x upper limit of normal
- •8. Adequate hepatic function within 28 days prior to the baseline visit
- •8.1. LFT < 1.5 x upper limit of normal
- •8.2. Serum amylase < 1.5 x upper limit of normal
- •8.3. Prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time (PTT) < 1.5 x upper limit of normal
- •8.3.1. Able to swallow tablets
- •9.3.2. Ppatients with the potential for pregnancy or impregnating their partner must agree to use acceptable methods of birth control to avoid conception
- •8.4. Female patients who are not using hormonal contraception must agree to employ two barrier methods of contraception (e.g. condom, diaphragm with spermicidal jelly) during the study and for 3 months following the end of their study participation
- •8.5. Female patients who are using hormonal contraception must agree to use an additional barrier method (e.g. condom or diaphragm with spermicidal jelly) during the study and for 3 months following the end of study participation
- •8.6. Post menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.
- •9. Women of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit
- •10. Male and female
- •11. Lower Age Limit 18 years
排除标准
- •1. Hypersensitivity to sorafenib or any of its excipients
- •2. Cardiac arrhythmias requiring antiarrhythmics (betablockers and digoxin are allowed)
- •3. Symptomatic coronary artery disease or ischemia
- •4. Myocardial infarction (MI) within the last six months; congestive cardiac failure > NYHA Class II
- •5. Active clinically serious bacterial or fungal infections
- •6. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
- •7. Pregnant or breastfeeding
- •8. Patients with uncontrolled hypertension
- •9. Serious uncontrolled concomitant medical or psychiatric illness
- •9.1. Concomitant medications which have adverse interactions with sorafenib: rifampicin, ritonavir, ketoconazole, itraconazole and St John?s Wort
- •10. Treatment with strong CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) which has not been discontinued or switched to a different medication at least 2
- •weeks prior to starting the study drug.
- •11. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St John?s Wort), which has not been discontinued or switched to a different medication at least 2 weeks prior to starting the study drug.
- •12. Grade 3 or higher impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)
- •13. History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis
- •14. History of another primary malignancy that is currently clinically significant or currently requires active intervention.
- •15. Any other clinically significant medical or surgical condition which, according to the CI/PI?s discretion, should preclude participation
- •16. History of significant congenital or acquired bleeding disorder
- •17. Patients taking warfarin or cytotoxic drugs
研究者
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