An Open-label Early Access Phase IIIb Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer (PRECONNECT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 907
- 试验地点
- 99
- 主要终点
- Abnormalities in laboratory assessment
研究概览
简要总结
The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC).
Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female participant aged ≥18 years old.
- •Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
- •Has metastatic lesion(s).
- •Has received at least 2 prior regimens of standard chemotherapies (including fluoropyrimidines, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and at least one of the anti-EGFR monoclonal antibodies for RAS wild-type patients) for mCRC and is refractory or intolerant to those chemotherapies or is not candidate for those chemotherapies.
- •Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 during the screening period.
- •Is able to take medications orally (i.e., no feeding tube).
- •Has adequate organ function.
- •Women of childbearing potential must have been tested negative in a serum pregnancy test within 7 days prior to first day of test drug administration. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use a highly effective method of birth control during the study and for 6 months after the discontinuation of study medication. Women and female partners using hormonal contraceptive must also use a barrier method.
排除标准
- •Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- •Eligible for enrolment into another available ongoing clinical study of trifluridine / tipiracil.
- •Has previously received trifluridine / tipiracil or hypersensitivity to the active substances or to any of the excipients of trifluridine / tipiracil.
- •Has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
- •Has certain serious illness or medical condition(s) described in the protocol.
- •Has had certain other recent treatment e.g. major surgery, anticancer therapy, radiation therapy, participation in another interventional study, within the specified time frames prior to first day of study drug administration.
- •Has unresolved toxicity of greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation, and platinum-induced neurotoxicity).
研究组 & 干预措施
S95005
Film-coated tablet containing 15 mg of trifluridine and 7.065 mg of tipiracil hydrochloride, or 20 mg of trifluridine and 9.42 mg of tipiracil hydrochloride, taken orally twice a day at the dose of 35 mg/m²/dose. The treatment is given until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.
干预措施: Trifluridine/Tipiracil hydrochloride (S95005) (Drug)
结局指标
主要结局
Abnormalities in laboratory assessment
时间窗: Through study completion, an average of 12 weeks
Incidence of Adverse Events [safety and tolerability]
时间窗: Through 28 days following last administration of study medication
Abnormalities in vital signs
时间窗: Through study completion, an average of 12 weeks
Abnormalities in performance status (ECOG)
时间窗: Through study completion, an average of 12 weeks
次要结局
- Quality of life using the questionnaire EORTC QLQ-C30(Through study completion, an average of 12 weeks)
- Progression free survival (PFS)(Through study completion, an average of 12 weeks)
- Quality of life using the questionnaire EQ-5D(Through study completion, an average of 12 weeks)