EUCTR2009-016019-39-PT进行中（未招募）1 期
AN OPEN-LABEL, MULTICENTER, RANDOMIZED, PHASE 3 STUDY OF S-1 AND CISPLATIN COMPARED WITH 5-FU AND CISPLATIN IN PATIENTS WITH METASTATIC DIFFUSE GASTRIC CANCER PREVIOUSLY UNTREATED WITH CHEMOTHERAPY - DIGEST
Taiho Pharma USA, Inc.0 个研究点目标入组 350 人开始时间: 2011年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
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
- •A patient must meet all of the following inclusion criteria to be eligible for enrolment in this study:
- •1. Has given written informed consent.
- •2. Has histologically confirmed by Central Pathology Review,
- •unresectable (at the time of screening for study eligibility), metastatic diffuse gastric cancer including carcinoma of the gastroesophageal
- •junction as defined in Appendix F (Pathology Central Review: Histologic Criteria). Patients must only be randomized after central pathology
- •review has confirmed diffuse histologic type. Gastro-esophageal junction involvement must be documented by endoscopic, radiologic, surgical or
- •pathology report.
- •3. Has had no prior chemotherapy for gastric cancer; however, adjuvant
- •and/or neo-adjuvant chemotherapy is permitted if more than 12 months have elapsed between the end of adjuvant or
- •neo-adjuvant therapy and first recurrence.
- •4. Has a life expectancy of at least 3 months.
- •5. Is able to take medications orally and without being crushed or removed from the capsule and given through any form of feeding tube.
- •6. Is =18 years of age.
- •7. First dose of study medication will be at least 3 weeks from prior
- •major surgery.
- •8. First dose of study medication will be at least 4 weeks from prior
- •radiotherapy.
- •9. Has an ECOG performance status 0 to 1 (see Appendix A).
- •10. Has adequate organ function as defined by the following criteria:
- •a. Aspartate aminotransferase (AST; SGOT) and alanine aminotransferase (ALT; SGPT) =2.5 × upper limit of normal (ULN); if
- •liver function abnormalities are due to underlying liver metastasis, AST
- •(SGOT) and ALT (SGPT) =5 × ULN.
- •b. Total serum bilirubin of =1.5 × ULN.
- •c. Absolute neutrophil count of =1,500/mm3 (ie, =1.5 × 109/L by
- •International Units [IU]).
- •d. Platelet count =100,000/mm3 (IU: =100 × 109/L).
- •e. Hemoglobin value of =9.0 g/dL based on measurements obtained
- •prior to any transfusions during the Baseline period.
- •f. Creatinine clearance (CrCl) =60 mL/min.
- •11. Is willing and able to comply with scheduled visits, treatment plans,
- •laboratory tests, and other study procedures.
- •12. Women of childbearing potential must have a negative pregnancy test (urine or serum) prior to randomization. Females and males must
- •agree to adequate birth control if conception is possible during the study; and males and females must agree to adequate birth control for up to 6 months after the discontinuation of study medication.
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Exclude a patient from this study if any of the following conditions are observed:
- •1. Has only the following type(s) of non-measurable lesion(s):
- •a. Ascites, pleural or pericardial effusions.
- •b. Previously irradiated lesions not in progression.
- •2. Has had treatment with any of the following within the specified time frame prior to study medication administration:
- •a. Any prior chemotherapy or any previous therapy for malignancy other than gastric cancer, including any chemotherapy, immunotherapy,
- •biologic or hormonal therapy, within the past 5 years.
- •b. Adjuvant or neo-adjuvant therapy within the past 12 months.
- •c. Treatment with any investigational agent within 30 days of
- •randomization.
- •d. Prior cisplatin as neo-adjuvant and/or adjuvant chemotherapy with
- •cumulative dose >360 mg/m2.
- •e. >25% of marrow-bearing bone radiated.
- •3. Has a serious illness or medical condition(s) including, but not limited to, the following:
- •a. Known acute systemic infection.
- •b. Known brain or leptomeningeal metastases.
- •c. Ascites =Grade 3 (ie, invasive intervention is indicated).
- •d. Other malignancies within the past 5 years, except adequately treated
- •carcinoma-in-situ of the cervix or non-melanoma skin cancer.
- •e. Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure New York Heart Association (NYHA) class III or IV (see Appendix E);
- •f. Chronic nausea, vomiting, or diarrhea.
- •g. Known human immunodeficiency virus (HIV) or acquired
- •immunodeficiency syndrome (AIDS)-related illness.
- •h. Any disorder that may interfere with consent and/or protocol
- •compliance.
- •i. Peripheral neuropathy, Grade 2 or higher.
- •j. Other severe acute or chronic medical or psychiatric condition or
- •laboratory abnormality that may increase the risk associated with study participation or study medication administration, or may interfere with the interpretation of study results, and in the judgment of the
- •Investigator would make the patient inappropriate for entry into this study.
- •4. Has lost =10% of their body weight in the preceding 3 months at time of signed ICF.
- •5. Is receiving treatment with drugs interacting with S-1, 5-FU, or cisplatin (see the required washout period before starting a patient on treatment [Section 6.6]). The following drugs are
- •prohibited:
- •a. Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinic acid, dipyridamole, flucytosine, methotrexate, and nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 and 5-FU activity).
- •b. Clozapine (may increase risk and severity of hematologic toxicity with S-1).
- •c. Allopurinol (may diminish 5-FU activity).
- •d. Ethyol (may diminish cisplatin activity [see package insert]).
- •6. Is a pregnant or lactating female.
- •7. Has known hypersensitivity to 5-FU or cisplatin.
- •Additional Criteria for Randomization Immediately prior to
- •randomization, the following criteria must be met:
- •1. Has not experienced =5% loss of their body weight between signed
- •ICF and randomization;
- •2. Has an ECOG performance status of 0 or 1 on Cycle 1, Day 1;
- •3. Has no sign of infection on Cycle 1 Day 1.
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