A phase I-II study to assess the safety, efficacy and pharmacokinetic profile of HM781-36B combined with Paclitaxel and Trastuzumab in patients with HER-2 positive advanced gastric cancer

Hanmi Pharm0 个研究点目标入组 48 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically confirmed advanced gastric cancer including gastroesophageal junction adenocarcinoma
•2.At least one measurable lesion defined by RECIST(v1.1)
•3.FISH+ or IHC3+ (regardless of FISH results)
•5.ECOG = 2
•6.Life expectancy = 12 weeks
•7.Adequate bone marrow and no abnormal heart and lung function
•8.No radiotherapy, other anticancer drugs or immunotherapy is allowed during this study
•9.Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

•1.Patients with a hitory of hypersensitivity to Trastuzumab and who have been treated with medicine including Cremophor EL
•2.Patients who have a current active malignancy other than gastric adenocarcinoma (with exception of non-melanoma skin cancer or cervical cancer in situ)
•3.Patients who have previously received taxane-based chemotherapy
•4.The presence of central nervous system metastases
•5.Patients who have a blood tumor such as leukemia, or who had previously received, or are planning to receive, the bone marrow transplant
•6.Patients with uncontrolled infection
•7.Patients who have GI malabsorption or difficulty taking oral medication
•8.LVEF (left ventricular ejection fraction) < 50% or NYHA (New York Heart Association) Class III or IV heart failure
•9.Patients with psychiatric or congenital disorder which can affect adherence or make hard to follow the requirements of the protocol
•10.Pregnant or breastfeeding women or women of childbearing who do not use an appropriate method of contraception (male patient should also use an appropriate method of contraception)

发起方

Hanmi Pharm