NCT02076230已完成1 期
A Phase I, Open-Label, Two-Center Trial to Investigate the Mass Balance and Metabolite Profile of TH-302 in Cancer Patients With Locally Advanced or Metastatic Solid Tumors
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
- 10
- 试验地点
- 1
- 主要终点
- Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM
研究概览
简要总结
This is an open-label, Phase 1, two-center trial to evaluate the mass balance and metabolite profile of carbon 14 [14C]-labeled TH-302 (Label 1 and Label 2) followed by subsequent treatment with unlabeled TH-302 in cancer subjects with locally advanced or metastatic solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject with pathologically or cytologically confirmed solid tumor which is locally advanced or metastatic, and either refractory to the standard therapy or for which no effective standard therapy is available
- •Subject has measurable and evaluable disease as RECIST version 1.1
- •Age greater than or equal to (>=) 18 years and less than or equal to (=<) 70 years
- •Body mass index (BMI) >= 19 and =< 33 kilogram per square meter (kg/m^2), body weight greater than (>) 50 kilogram (kg)
- •Eastern cooperative oncology group (ECOG) performance status of 0 to 1
- •Life expectancy of at least 3 months
- •At least 4 weeks from previous cytotoxic chemotherapy or radiation therapy and at least 5 half-lives or 6 weeks, whichever is longer, after targeted or biologic therapy
- •Acceptable renal function, liver function and hematologic status as defined in the protocol
- •Other protocol-defined inclusion criteria could apply
排除标准
- •New York Heart Association (NYHA) Class 3 or 4 congestive heart disease, myocardial infarction within 6 months, unstable arrhythmia, symptomatic ischemic heart disease or symptomatic peripheral arterial vascular disease
- •Severe chronic obstructive or other pulmonary disease with hypoxemia as defined in the protocol
- •Major surgery, other than diagnostic surgery, =< 28 days prior to Day
- •Subject must have completely recovered from surgery
- •Primary brain tumors or clinical evidence of active brain metastasis as defined in the protocol
- •Treatment with strong inhibitors and/or inducers of drug metabolic enzymes or drug transporter as defined in the protocol
- •Participation in a drug trial within 30 days prior to start of trial medication. Participation in a trial involving administration of 14C-labeled compound(s) within last 6 months prior to start of study drug
- •Inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial
- •Legal incapacity or limited legal capacity
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
[14C] TH-302 (Label 1)
Experimental
干预措施: [14C] TH-302 (Label 1) (Drug)
[14C] TH-302 (Label 1)
Experimental
干预措施: Unlabeled TH-302 (Drug)
[14C] TH-302 (Label 2)
Experimental
干预措施: [14C] TH-302 (Label 2) (Drug)
[14C] TH-302 (Label 2)
Experimental
干预措施: Unlabeled TH-302 (Drug)
结局指标
主要结局
Pharmacokinetics profile in plasma: Cmax, Tmax, AUC (0-t), lambda_z, t1/2, AUC (0-infinity), CL, Vss, Vz, MRT for TH-302 and its active metabolite Br-IPM
时间窗: Days 1 and 8 of Cycle 1
Pharmacokinetics profile in excreta: Cumulative Ae (0-t), Ae (0-infinity), percent radioactive dose excreted in urine and feces, AeUF, CLR, CLNR for TH-302 and its active metabolite Br-IPM
时间窗: Day 1 of Cycle 1
次要结局
- Number of subjects with Treatment-emergent adverse events (TEAEs)(Baseline up to Day 30 after the last dose of study treatment)
- Blood to plasma ratio of total 14C-radioactivity(Days 1 and 8 of Cycle 1)
- Total and free plasma concentrations of TH-302 in plasma(Day 1 of Cycle 1)
- Number of subjects with tumor response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)(Up to 1 year)
- Unbound fraction (fu) of TH-302 in plasma(Day 1 of Cycle 1)
研究者
研究点 (1)
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