NCT03974594已完成1 期
Single-Dose, Randomized, Open-Label, Two-Way Crossover Study to Evaluate the Bioequivalence of Trifluridine and Tipiracil Tablets in Colorectal Cancer Patients Under Fasting or Postprandial Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- AUC(0-infinity)
研究概览
简要总结
Trifluridine and Tipiracil Tablets is a nucleoside anti-metabolic and anti-cancer compound developed by Taiho (Dapeng) Co., Ltd., Japan, for the treatment of advanced colorectal cancer that inoperable resection, and progressed or relapsed after standard treatment. This study mainly evaluates bioequivalence, safety and tolerance of Trifluridine and Tipiracil Tablets in colorectal cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old, life expectancy ≥ 3 months.
- •Histologically confirmed colon or rectal adenocarcinoma.
- •Has not received anti-tumor therapy before 4 weeks of first dose or Traditional Chinese Medicine anti-tumor therapy before 2 weeks of first dose.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Has ability to take oral medication.
- •The main organs function are normally, the following criteria are met:
- •Hemoglobin (HB) ≥ 100 g / L;
- •Absolute neutrophil count (ANC) ≥1.5×109/L;
- •Platelets (PLT) ≥ 80 × 109 / L;
- •Total serum bilirubin (TBIL) ≤ 1.5 × ULN;
- •Alanine transaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 × ULN (when the liver is invaded，AST ≤ 5×ULN);
- •Serum creatinine ≤ 132.6 μmol / L.
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
- •Understood and signed an informed consent form.
排除标准
- •Has serious diseases , including but not limited to:
- •Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include carcinoma in situ of cervix, non-melanoma skin cancer and superficial bladder tumor;
- •Has brain metastases;
- •Has active infection (such as infection caused body temperature ≥ 38 ° C);
- •Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage before 4 weeks of first dose;
- •Has intestinal obstruction, pulmonary fibrosis, renal failure, liver failure or symptomatic cerebrovascular disease;
- •Has uncontrolled diabetes (fasting blood glucose (FBG) > 10mmol/L);
- •Has myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure within 12 months prior to first dose;
- •Has gastrointestinal bleeding;
- •Has HIV infection, or active hepatitis B or C;
- •Has a history of organ transplants or autoimmune disease required immunosuppressive therapy;
- •Has increased risk associated with participating in the study or taking the study drug, or mental disorders may interfere with the results of the study.
- •Has received any of the following treatments before the first dose:
- •Has received partial or total gastrectomy;
- •Has surgery (such as laparotomy, thoracotomy, and laparoscopic resection of the viscera and/or unhealed wounds) within 4 weeks;
- •Has any study drug within 4 weeks.
- •Prior therapy with TAS-
- •Has adverse events caused by previous therapy except alopecia that did not recover to ≤ grade
- •Pregnant or lactating woman.
- •Subjects who, in the opinion of the investigators, should not participate in the study.
研究组 & 干预措施
Trifluridine and Tipiracil Tablets
Experimental
干预措施: Trifluridine and Tipiracil Tablets (Drug)
TAS-102
Active Comparator
干预措施: TAS-102 (Drug)
结局指标
主要结局
AUC(0-infinity)
时间窗: 3 days
The AUC(0-infinity) is area under the serum concentration-time curve from time zero to infinite time.
AUC(0-t)
时间窗: 3 days
The AUC(0-t) is area under the serum concentration-time curve from time zero to t.
Bioequivalence based on Peak Plasma Concentration (Cmax)
时间窗: 3 days
The Cmax is observed maximum serum concentration, taken directly from the serum concentration-time profile
次要结局
- Adverse Event(Up to 4 weeks)
研究者
研究点 (1)
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