The clinical study to assess the safety, efficacy and pharmacokinetic profile of HM781-36B combined with Paclitaxel and Trastuzumab in patients with advanced gastric cancer
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000606
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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)
4.Age=19
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)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose limiting toxicity
- Secondary Outcome Measures
Name Time Method Disease Control Rate (CR, PR, SD), PFS(Progression-Free Survival), TTP (Time To Tumor Progression), and DOR (Duration of Overall Response)