A Phase 1, Open-label Study to Evaluate the Mass Balance of Orally Administered FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI
研究概览
简要总结
The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI.
详细描述
This is a Phase 1, open-label study evaluating the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of [14C]FTD or [14C]TPI. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists
- •ECOG performance status of 0 or 1
- •Is able to take medications orally
- •Has adequate organ function (bone marrow, kidney and liver)
- •Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
排除标准
- •Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- •Certain serious illnesses or medical condition(s)
- •Has had either partial or total gastrectomy
- •Has a medical condition that jeopardizes or impairs ability to collect representative excreta
- •Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- •Known sensitivity to TAS-102 or its components
- •Is a pregnant or lactating female
- •Refuses to use an adequate means of contraception (including male patients)
- •Is an occupationally exposed worker as defined by relevant ionizing radiation regulations
- •Has been exposed to 14C in the last 12 months
研究组 & 干预措施
TAS-102 with light tracer dose of [14C]FTD
干预措施: TAS-102 with a light tracer dose of [14C]FTD (Drug)
TAS-102 with light tracer dose of [14C]FTD
干预措施: TAS-102 tablets (Drug)
TAS-102 with light tracer dose of [14C]TPI
干预措施: TAS-102 with a light tracer dose of [14C] TPI (Drug)
TAS-102 with light tracer dose of [14C]TPI
干预措施: TAS-102 tablets (Drug)
结局指标
主要结局
Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI
时间窗: Day 1 through day 8 (through 168 hours postdose)
Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose. For \[14C\]FTD only, samples of CO2 will be trapped from expired air immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose.
PK parameters of total radioactivity (AUC0-inf, AUC0-last, Cmax, Tmax, and T1/2) in whole blood and plasma after a single dose of TAS-102
时间窗: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
PK parameters of FTD, FTY, and TPI in plasma (Cmax, Tmax, AUC0-last, AUC0-inf, T1/2, CL/F, and Vd/F)
时间窗: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose.
Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2 will be calculated for each analyte, and CL/F and Vd/F will be calculated for FTD and TPI
Metabolic profile of FTD and TPI in plasma, urine, and feces
时间窗: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose. Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose.
Characterization of FTD and TPI metabolites
次要结局
- Safety monitoring including adverse events, vital signs, and laboratory assessments(Through 30 days following last administration of study medication or until initiation of new anticancer treatment, whichever comes first)
- Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)(Every 8 weeks during the extension phase through Cycle 6 (through 24 weeks) and at least every 12 weeks thereafter, until treatment discontinuation (ie, due to disease progression, AEs, patient death, physician decision, pregnancy, or patient request))