NCT02720926终止1 期
A Phase 1 Study of TKI 258 in Combination With Xeloda and Oxaliplatin in Upfront Treatment of Advanced Colorectal and Gastric Cancer With a Dose Expansion Cohort in Advanced Gastric Cancer
National Cancer Centre, Singapore1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Determine the recommended phase 2 dose of TKI258 in combination with XELOX (Capecitabine and Oxaliplatin)
研究概览
简要总结
Standard "3+3" dose escalation design of TKI258/XELOX in advanced gastric/gastro-oesophageal and colorectal cancer.
详细描述
This is a "3+3" dose escalation design with 4 pre-defined TKI258 dose levels (200mg, 300mg, 400mg and 500mg daily with 5 days on and 2 days off schedule) in combination with a fixed standard dose of XELOX (Capecitabine and Oxaliplatin) to establish the recommended phase 2 dose.
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
- •Patients must have histologically confirmed gastric, gastro-oesophageal or colorectal adenocarcinoma.
- •The gastric or gastro-oesophageal cancer must be locally advanced unresectable or metastatic. Colorectal cancer must be metastatic and for which subsequent resection of all metastatic disease is assessed not to be feasible.
- •Age >18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%, see Appendix A).
- •Life expectancy of greater than 3 months
- •Patients must have normal organ and marrow function as defined below:
- •leukocytes >3,000/mcL
- •absolute neutrophil count >1,500/microliter (mcL) TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 3
- •platelets >100,000/mcL
- •total bilirubin <= 1.5 x upper limit of normal (ULN)
- •aspartate aminotransferase (AST)/alanine aminotransferase (ALT) <2.5 X institutional upper limit of normal
- •creatinine within normal institutional limits OR
- •creatinine clearance >55 mL/min for patients with creatinine levels above institutional normal.
- •The effects of TKI258 and XELOX on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Baseline left ventricular ejection fraction (LVEF) >= 50%
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients are not considered to have a "currently active" malignancy if they have TKI258/XELOX phase 1 protocol version 3.3 Dated 30 November 2011 1 4 completed therapy and are considered to have a less than 30% risk of relapse.
- •Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TKI258 or XELOX, breastfeeding should be discontinued if the mother is treated with TKI258 or XELOX.
- •Patients with prior history of transient ischemia attack or cerebrovascular disease or prior history of ischemia heart disease or myocardia infarction and 2 or more risk factors: ever smoker with > 30 packs per year exposure or on medication for diabetes mellitus or hypertension or hyperlipidemia.
- •In addition for the Beginning at dose expansion cohort, the following exclusion criteria apply:
- •Patients who are not agreeable for collection of tumor tissue for correlative studies
- •Patients from whom tumor tissue for correlative studies cannot be safely obtained.
研究组 & 干预措施
TKI258 combined with Xeloda/Oxaliplatin
Experimental
TKI258 200 mg once a day (OD) 5 days on/2 days off Capecitabine (Xeloda) 2000 mg/m2 bid d1-14 Oxaliplatin 130mg/m2 d1 q21days
干预措施: Xeloda, (Drug)
TKI258 combined with Xeloda/Oxaliplatin
Experimental
TKI258 200 mg once a day (OD) 5 days on/2 days off Capecitabine (Xeloda) 2000 mg/m2 bid d1-14 Oxaliplatin 130mg/m2 d1 q21days
干预措施: Oxaliplatin (Drug)
TKI258 combined with Xeloda/Oxaliplatin
Experimental
TKI258 200 mg once a day (OD) 5 days on/2 days off Capecitabine (Xeloda) 2000 mg/m2 bid d1-14 Oxaliplatin 130mg/m2 d1 q21days
干预措施: TKI258 (Drug)
结局指标
主要结局
Determine the recommended phase 2 dose of TKI258 in combination with XELOX (Capecitabine and Oxaliplatin)
时间窗: 42 days
次要结局
- Describe the toxic effects of TKI258 when administered in combination with XELOX chemotherapy.(one year)
- Measure the Area under the plasma concentration versus time curve (AUC) of TKI258 at specific timepoints(42 days)
研究者
研究点 (1)
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