NCT03810742已完成1 期
Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
PharmaEngine2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年3月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Determination of Dose Limiting Toxicities (DLT)
研究概览
简要总结
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers
详细描述
Primary Objectives
- to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
- to evaluate the toxicity profile of the combination therapy Secondary Objectives
- to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®)
- to study the pharmacokinetics of the combination therapy
A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 20 to 70 years old
- •Histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed standard treatment or have no standard treatment currently available
- •ECOG performance status 0 or 1
- •Normal ECG or ECG without any clinically significant findings
- •Adequate hematologic parameters, and hepatic and renal function i. White blood cell (WBC) count 3000/μL and absolute neutrophil count (ANC) 1500/μL ii. Platelet counts 100,000/μL without platelet transfusion within 14 days iii. Hemoglobin level 10 g/dL iv. Serum total bilirubin- within normal range v. Serum albumin 3.0 g/dL vi. Serum alanine aminotransferase (ALT) 3 x the upper limit of normal (ULN) vii. Serum creatinine 1.5 x ULN
排除标准
- •Received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) therapy
- •Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
- •Have liver cirrhosis with Child-Pugh B or Child-Pugh C
- •With active CNS metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- •With clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- •Life expectancy of less than 3 months
- •Use any anti-cancer or investigational product within 14 days prior to the first date of study dosing
- •History of any second malignancy in the latest 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ
- •Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, and psychiatric illness or social situation that would preclude study compliance
- •Homozygous for the UGT1A1 28 allele (TA7/TA7), homozygous for UGT1A1 6 allele (A/A), or double heterozygous for both UGT1A1 28 allele (TA6/TA7) and UGT1A1 6 allele (G/A) (only for dose-finding phase)
- •Pregnant or breastfeeding women
研究组 & 干预措施
Nanoliposomal Irinotecan + TAS-102
Experimental
different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
干预措施: Nanoliposomal Irinotecan (Drug)
结局指标
主要结局
Determination of Dose Limiting Toxicities (DLT)
时间窗: 12 months
to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events
时间窗: 12 months
Incidence of Treatment-Emergent Adverse Events \[Safety\] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0
次要结局
- Pharmacokinetics study - (CL)(6 months)
- Pharmacokinetics study - (AUC0→∞)(6 months)
- Pharmacokinetics study - (Tmax)(6 months)
- Pharmacokinetics study - (T1/2)(6 months)
- Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST)(24 months)
- Pharmacokinetics study - (Cmax)(6 months)
- Pharmacokinetics study - (AUC0→t)(6 months)
研究者
研究点 (2)
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