KCT0003583已完成未知
A TWO PART, PHASE IB/II, OPEN LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF VARLITINIB IN COMBINATION WITH WEEKLY PACLITAXEL IN EGFR/HER2 CO-EXPRESSING ADVANCED OR METASTATIC GASTRIC CANCER PATIENTS.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 73
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Capable of understanding and complying with the requirements of the study and have signed the Informed Consent Form (ICF).
- •2. Able to communicate well with the Investigator and understand and comply with the requirements of the study.
- •3. Has a histologically or cytologically confirmed diagnosis of advanced or metastatic gastric adenocarcinoma (systemic metastasis or locally advanced unresectable gastric cancer). A subject must have previously received 1st line chemotherapy including fluoropyrimidine and/or platinum and have showed progression.
- •4. Not received paclitaxel-based chemotherapy previously.
- •5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or1
- •6. Has a measurable or evaluable disease as determined by RECIST 1.1 criteria.
- •7. Able to swallow orally administered medication.
- •8. Life expectancy of at least 3 months
- •9. Has an adequate baseline organ function defined as:
- •- White blood cells =3000/mm3 and neutrophils =1500/mm3
- •- Platelets =100000/mm3
- •- Hemoglobin =9.0 g/dL
- •- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =3.0 × upper limit of normal (ULN) of the study site (or =5.0 × ULN in patients with liver metastases)
- •- Total bilirubin =2.0 × ULN
- •- Creatinine=1.5 × ULN or creatinine clearance (either measured value or estimated value using the Cockcroft-Gault equation) >60ml/min.
- •10. Provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for central analysis of EGFR and HER2 expression status.
- •11. Tumours with immunohistochemistry (IHC) evidence of expression of HER1 (at level of +, or ++, or +++) and HER-2 (at level of +, or ++, or +++) using standard criteria. Also, Subjects with HER-2 IHC (at level of +, or ++, or +++) and EGFR gene amplification/ mutation by NGS are included.
排除标准
- •1. Has multiple cancers
- •2. Has a current or past history of interstitial lung disease or pulmonary fibrosis diagnosed on imaging (preferably CT) or clinical findings
- •3. Has brain or leptomeningeal metastases. Patients may be randomized for the study if they are asymptomatic and require no treatment.
- •4. History of uncontrollable or significant cardiovascular disease meeting any of the following;
- •- myocardial infarction within 180 days before study enrolment
- •- uncontrolled angina pectoris within 180 days before study enrolment
- •- New York Heart Association (NYHA) Class III or IV congestive heart failure
- •- uncontrolled hypertension despite appropriate treatment (e.g., systolic blood pressure =150mmHg or diastolic blood pressure =90 mmHg lasting 24 hours or more)
- •- arrhythmia requiring treatment
- •- baseline corrected QT interval (Fridericia’s formula) (QTcF) > 450 ms or patients with known long QT syndrome; torsade de pointes
- •5. Has an active systemic infection requiring treatment.
- •6. Has a contraindication to paclitaxel.
- •7. Has undergone surgery (any surgery involving general anesthesia) within 28 days before study treatment.
- •8. Subjects with malabsorption syndrome, diseases significantly affecting gastrointestinal function, has total gastrectomy, or difficulty in swallowing and retaining oral medications.
- •9. Has received radiotherapy for gastric cancer within 28 days before treatment or radiotherapy for bone metastases within 14 days before treatment
- •10. Positive test result for human immunodeficiency virus-1 (HIV-1) antibody, Hepatitis B surface protein (HBs) antigen and HBV titer>2000 IU/ml (10,000 copy/ml), or hepatitis C virus (HCV) antibody positive result
- •11. Any unresolved ? Grade 2 (per CTCAE v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or anemia
- •12. Previously treated with varlitinib
- •13. Unable to comply to the study protocol
- •14. Have participated in a study involving another investigational drug within 21 days prior to the first dose of study drug
- •15. Has a history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the study drug.
研究者
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