EUCTR2008-000066-22-GB进行中（未招募）1 期
A Phase 2 study of Sorafenib (BAY 43-9006) in patients with advanced salivary Adenoid Cystic Carcinoma
Christie Hospital NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2008年2月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
入选标准
- •1) Age > 18 years old
- •2) Histological diagnosis of adenoid cystic carcinoma of the head and neck which is locally recurrent and/or metastatic
- •3) Patients with at least one uni-dimensional 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 10.3)
- •4) Life expectancy of at least 12 weeks
- •6) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
- •7) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
- •8) Ability to understand the patient information sheet and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
- •9) ECOG performance status of 0 or 1.
- •Are the trial subjects under 18? no
- •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) History of cardiac disease: congestive heart failure >NYHA (New York Heart Association) class 2; active CAD (Coronary artery disease) (Myocardial Infarction 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
- •2) Known history of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C
- •3) Active clinically serious infections (> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0)
- •4) Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
- •5) Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.
- •6) History of organ allograft
- •7) Patients taking prophylactic warfarinwho are unable to convert to low molecular weight heparin
- •8) Patients who are taking cortocosteroids and whose steroid therpay cannot be stopped
- •9) Patients with evidence or history of bleeding diathesis or coagulopathy
- •10) Patients undergoing renal dialysis
- •11) Cancer other than salivary adenoid cystic carcinoma within 5 years prior to start of study treatment 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)]
- •12) Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- •13) Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •14) Pulmonary haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- •15) Any other haemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- •16) Serious, non-healing wound, ulcer, or bone fracture.
- •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 birth control measures (such as a male condom) during the course of the 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) Known or suspected allergy to the investigational agent or any agent given in association with this trial.
- •20) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
- •21) Patients unable to swallow oral medications.
- •22) Any malabsorption condition
- •23) History of severe skin disease, including hand-foot syndrome
研究者
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