DRKS00004844已完成1 期
A phase 1, open-label, non-randomized, dose-finding, safety and tolerability study of orally administered Teysuno (S1) in combination with Epirubicin and Oxaliplatin in patients with advanced solid tumors - TPU-S1119
Disphar International B.V.0 个研究点目标入组 12 人开始时间: 2013年6月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Has given written informed consent.
- •2. Is =18 years of age.
- •3. Has advanced or metastatic solid tumor(s) for which no established curative therapy exists.
- •4. May have received any number of prior therapies for advanced or metastatic disease.
- •5. Is able to take medications orally.
- •6. Has ECOG performance status 0 or 1 on Cycle 1, Day 1.
- •7. Has a life expectancy of at least 3 months.
- •8. Left ventricular ejection fraction (LVEF) = the lower limit of normal (LLN) for the institution.
- •9. Serum troponin T and creatine phosphokinase (CPK)-MB values = upper limit of Normal (ULN) for the institution.
- •10. Has adequate organ function as defined by the following criteria:
- •a. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) =2.5 x ULN; if liver function abnormalities are due to underlying liver metastasis, AST (SGOT) and ALT (SGPT) =5 x ULN.
- •b. Total serum bilirubin of =1.5 x ULN.
- •c. Absolute neutrophil count of =1,500/mm3 (ie, =1.5 x 109/L by International Units [IU])
- •(excluding measurements obtained within 7 days after administration of G-CSF).
- •d. Platelet count =100,000/mm3 (IU: =100 x 109/L) (excluding measurements obtained within 7 days after transfusion).
- •e. Hemoglobin value of =9.0 g/dL (excluding measurements obtained within 7 days after
- •transfusion).
- •f. Creatinine clearance =60 mL/min based on calculated creatinine clearance (Cockcroft-
- •Gault32 formula) or 24-hour urine collection.
- •g. Is willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.
排除标准
- •1. Has had treatment with any of the following within the specified time frame prior to study drug administration:
- •a. Major surgery within prior 4 weeks (the surgical incision should be fully healed prior to study drug administration).
- •b. Radiotherapy within prior 4 weeks.
- •c. >25% of marrow-bearing bone radiated.
- •d. Any chemotherapy within prior 3 weeks.
- •e. Previously received oxaliplatin or S-1.
- •f. Previously received epirubicin with cumulative dose >350 mg/m2 (patients who have received epirubicin with cumulative dose =350 mg/m2 as adjuvant therapy are allowed to enroll).
- •g. Extensive prior exposure to other anthracycline or anthracenedione agents (ie, prior cumulative doxorubicin exposure of =450 mg/m2 or prior mitoxantrone exposure of >100 mg/m2)
- •h. Received trastuzumab (cardiotoxic agent) within prior 24 weeks.
- •i. Any investigational agent received either concurrently or within the last 30 days.
- •j. Current enrollment in another interventional clinical study.
- •2. Has a serious illness or medical condition(s) including, but not limited to, the following:
- •a. Known brain metastasis or leptomeningeal metastasis.
- •b. Known acute systemic infection.
- •c. Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or deep vein thrombosis within the last 12 months.
- •d. Symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV e. Ongoing cardiac dysrhythmias (=Grade 2),
- •atrial fibrillation (any grade), or prolongation of QTc interval (>450 msec for males; >470 msec for females).
- •f. Hypertensive crisis or severe hypertension that is not controlled.
- •g. Chronic nausea, vomiting, or diarrhea considered to be clinically significant in the opinion of the Investigator.
- •h. =Grade 1 peripheral neuropathy.
- •i. Recent hemoptysis, coagulopathy and other bleeding disorders considered by the Investigator to be clinically significant.
- •j. Known nephrotic syndrome (proteinuria >2 g/24 hours).
- •k. Known clinically significant interstitial lung disease or pulmonary fibrosis.
- •l. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- •m. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug 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.
- •3. Is receiving concomitant treatment with the following drugs that may interact with S-1:
- •a. Sorivudine, brivudine, uracil, eniluracil, cimetidine, folinate/folinic acid, and dipyridamole (may enhance S-1 activity).
- •b. Nitroimidazoles, including metronidazole and misonidazole (may enhance S-1 activity)
- •c. Methotrexate (may enhance S-1 activity)
- •d. Clozapine (may increase risk and severity of hematologic toxicity with S-1)
- •e. Allopurinol (may diminish S-1 activity).
- •f. Phenytoin (S-1 may enhance phenytoin activity).
- •g. Flucytosine, a fluorinated pyrimidine antifungal agent (may enhance S-1 activity).
- •4. Is receiving concomitant treatment with the following drugs that may interaction with epirubicin:
- •a. Cimetidine (may increase the area under the plasma concentrationtime curve [AUC] of epirubicin).
- •b. Dexverapamil (may alter the pharmacokinetics of epirubicin).
- •c. Quinine (may accelerate the initial distribute on of epiru
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