EUCTR2008-005062-31-IE进行中（未招募）不适用
Phase II single agent sorafenib in the treatment of relapsed oesophageal/gastric adenocarcinoma in platinum pre-treated patients - Sorafenib upper GI study
ICORG, the all-Ireland Co-operative Oncology Research Group0 个研究点目标入组 54 人开始时间: 2008年10月8日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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
- •Relapsed or progressed histologically confirmed oesophageal and/or gastric adenocarcinoma after prior platinum based chemotherapy not suitable for radical therapy.
- •Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug.
- •Prior surgery is allowed if it is performed at least 4 weeks prior to the first dose of study drug.
- •Subjects with at least one uni-dimensional measurable lesion as assessed by the RECIST criteria.
- •Age > 18 years old.
- •ECOG Performance Status of 0 to 2.
- •Life expectancy of at least 2 months.
- •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:
- •- Haemoglobin > or = 9.0 g/dl.
- •- Absolute neutrophil count (ANC) ³ 1.5 x 10^9/L.
- •- Platelet count >or = 100 x 1^09/L.
- •- Total bilirubin > 1.5 times the upper limit of normal.
- •- ALT and AST < or = 2.5 x upper limit of normal (< or = 5 x upper limit of normal for patients with liver involvement).
- •- Alkaline Phosphatase < or = 2.5 x upper limit of normal (< or = 4 x upper limit of normal for patients with bony involvement).
- •- INR (international normalised ratio) <1.5, and aPTT (activated partial thromboplastin time) within normal limits.
- •- Creatinine =1.5 times the upper limit of normal.
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment.
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
- •Ability to understand and the willingness to sign a written informed consent, given according to ICH/GCP, and national/local regulations. A signed informed consent must be obtained prior to any study specific procedures.
- •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
- •Cardiac disease: History of cardiac disease: congestive heart failure >NYHA class 2; active Coronary Artery Disease (Mycardial Infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- •Known human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.
- •Active clinically serious infections > or = CTCAE Grade 2.
- •Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
- •Pulmonary haemorrhage/bleeding event > or = CTCAE Grade 2 within 4 weeks of first dose of study drug.
- •Any other haemorrhage/bleeding event > or = CTCAE Grade 3 within 4 weeks of first dose of study drug.
- •Serious, non-healing wound, ulcer (apart from the tumour), or bone fracture.
- •Evidence or history of bleeding diathesis or coagulopathy.
- •Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug.
- •Current signs or symptoms of severe progressive or uncontrolled hepatic, haematological, renal, endocrine, pulmonary or cardiac disease.
- •Uncontrolled, symptomatic brain metastases – intracranial bleeding into metastases with tyrosine kinase inhibitors (TKI's) appears to be rare in other solid tumours and in our view should not exclude patients with well controlled disease from the study. The patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
- •Previous treatment with a tyrosine kinase inhibitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab.
- •Any previous drug treatment (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway.
- •Investigational drug therapy during or within 30 days.
- •Concomitant treatment with rifampin or St. John's Wort.
- •Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the previous 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted.
- •Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except bisphosphonates.
- •Women who are pregnant, nursing, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment).
- •Therapeutic anticoagulation with vitamin K antagonists such as warfarin, or with heparins or heparinoids. Low dose warfarin (1 mg p.o. qd) is permitted if the INR is < 1.5. Low-dose aspirin is permitted.
- •Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- •Previous cancer that is distinct in primary site or histology from oesophago-gastric junction cancer excluding cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumours [Ta and Tis] or any cancer curatively treated > 3 years prior to study entry.
- •Concurrent cancer that is distinct in primary site or histology from oesophago-gastric cancer.
- •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
- •Any condition that impairs patient’s ability to swallow w
研究者
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