KCT0000348尚未招募未知
Phase II Open Label Study to Evaluate the Biological Activity of ASLAN001 (ARRY 334543) in Patients With Recurrent/Metastatic Gastric, Gastro-oesophageal Junction, and Oesophageal Carcinoma Whose Tumours are Epidermal Growth Factor Receptor 2 (HER-2) Amplified or Co-Expressing Epidermal Growth Factor Receptor 1 (HER-1) and HER 2
Pharmanet Korea0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 21(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Male or female patients 21 years of age or older at the time of written informed consent is obtained.
- •2) Patients with histologically confirmed adenocarcinoma of the stomach, gastrooesophageal junction or distal oesophagus with inoperable locally-advanced
- •metastatic disease.
- •3) Patients with tumours with immunohistochemical evidence of expression of HER- 1 (at level of + or ++ or +++) and HER-2 (at level of + or ++ or +++) using standard criteria or tumours with gene-amplification of HER-2 by standard FISH.
- •4) Patient has received 1 or more prior chemotherapy for the treatment of adenocarcinoma of the stomach, gastro-oesophageal junction or distal oesophagus
- •with metastatic disease.
- •5) Patients with prior partial gastrectomy if they can take oral medications, can undergo gastroendoscopic biopsies and meet all other inclusion/exclusion criteria.
- •6) Patients with measurable or non-measurable disease per modified RECIST guidelines. All scans and x-rays used to document measurable or non-measurable
- •disease must be done within 28 days prior to enrolment.
- •7) Patients with Eastern Cooperative Oncology Group (ECOG) (Appendix 2) performance status of 0 or 1 (within 14 days prior to enrolment).
- •8) Patients with adequate organ and haematological function as evidenced by the following laboratory studies within 14 days prior to enrolment: o Haematological function, as follows:
- •-Absolute neutrophil count (ANC) = 1.5 x 109/L
- •-Platelet count = 75 x 109/L
- •-Haemoglobin = 9 g/dL
- •o Coagulation functions, as follows:
- •-Partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) = 1.5 x upper limits of normal (ULN) per institutional laboratory normal range
- •-International normalized ratio (INR) = 1.5
- •o Renal functions, as follows:
- •-Serum creatinine = 1.5 x ULN
- •-Urea = 1.5 x ULN
- •o Hepatic function, as follows:
- •-Total bilirubin = 1.5 x ULN
- •-Serum glutamic oxaloacetic transaminase (SGOT) (AST) and Serum glutamic pyruvic transaminase (SGPT) (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases are present)*.
- •*Except where due to direct disease involvement of the liver at the discretion of the investigator.
- •9) Able to provide written informed consent.
- •10) Able to communicate well with the Investigator, and understand and comply with the requirements of the study.
排除标准
- •1) Patients unable to swallow oral medications.
- •2) Patients with persistent gastric outlet obstruction, complete dysphagia or feeding jejunostomy.
- •3) Patients with total gastrectomy.
- •4) Patients who underwent radiotherapy to the gastric remnant = 14 days prior to enrolment. Patients must have recovered from all radiotherapy-related toxicities.
- •5) Patients who have uncontrolled, clinically significant symptomatic cardiovascular diseases within 6 months prior to enrolment, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure or arrhythmias not controlled by outpatient medication.
- •6) Patients with ongoing or clinically significant active infection as judged by the Investigator.
- •7) Patients with known positive test for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B surface antigen.
- •8) Pregnant (i.e., positive beta-human chorionic gonadotropin test) or breast-feeding women.
- •9) Patients who had inability to comply with protocol and/or were not available for follow-up assessments.
- •10) Patients who have received any investigational drug (or have used an investigational device) within the 30 days before receiving the first dose of study
- •medication.
研究者
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