NCT05382364进行中（未招募）1 期
A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of Tucatinib (MK-7119) in China Participants With HER2+ Advanced Breast Cancer, Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Percentage of participants with ≥1 adverse event (AE)
研究概览
简要总结
The primary purpose of this study is to characterize the safety and tolerability of tucatinib (MK-7119) in Chinese participants with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma (GEC), and colorectal cancer.
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
- •Histologically or cytologically confirmed HER2+ advanced breast cancer, gastric or GEC, and colorectal cancer
- •Have progressed at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy
- •Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance within 7 days prior to allocation
- •Has life expectancy >6 months in the opinion of the investigator
- •Have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiologist
- •Must test negative for hepatitis B surface antigen (HBsAg)
- •If there is a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening
- •For males, agree to be abstinent from heterosexual intercourse, or agree to use acceptable contraception, for the duration of study and 1 week after
- •For females, is not pregnant or breastfeeding AND one of the following applies:
- •Is not a woman of childbearing potential (WOCBP)
- •Is a WOCBP and uses highly effective contraception and is not pregnant
排除标准
- •History of prior cancer within <3 year, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas which needs discussion between the investigator and the Sponsor
- •Participants with leptomeningeal disease are excluded
- •Has symptomatic central nervous system (CNS) metastases
- •Has active human immunodeficiency virus (HIV), hepatitis B virus, or HCV infection
- •Has had chemotherapy, immunotherapy, radioimmunotherapy, definitive radiation, or biological cancer therapy or treatment with an investigational product within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention
- •Has an active infection requiring therapy
- •Has refractory nausea/vomiting, chronic gastrointestinal disease, or significant bowel resection
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study
- •Has a QTc prolongation
- •Has uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness that would limit compliance with study requirements
- •Has had major surgery within 4 weeks prior to first dose of study intervention
- •Is currently participating in another clinical trial
- •Has psychiatric or substance abuse disorder
研究组 & 干预措施
Tucatinib Treatment
Experimental
Chinese participants with HER2+ advanced breast cancer, gastric or gastroesophageal junction adenocarcinoma, or colorectal cancer receive tucatinib 300 mg by mouth twice daily during 21-day cycles. Treatment continues until there is evidence of unacceptable toxicity or documented progression.
干预措施: Tucatinib (Drug)
结局指标
主要结局
Percentage of participants with ≥1 adverse event (AE)
时间窗: Up to approximately 2.5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of participants discontinuing from study therapy due to AE
时间窗: Up to approximately 2.5 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
- Time of maximum plasma concentration (Tmax) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Maximum plasma concentration (Cmax) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Area under the plasma concentration time curve from dosing to 12 hours postdose (AUC0-12) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Apparent plasma half-life (t½) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Apparent clearance (CL/F) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Volume of distribution (Vz/F) of first dose of tucatinib(Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Trough concentration (Ctrough) of tucatinib at steady state(Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Accumulation ratio of tucatinib at steady state(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Cmax at steady state (Cmaxss) of tucatinib(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Tmax at steady state (Tmaxss) of tucatinib(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- AUC0-12 at steady state (AUC0-12ss) of tucatinib(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- t½ of tucatinib at steady state(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- CL/F at steady state (CL/Fss) of tucatinib(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Vz/F at steady state (Vz/Fss) of tucatinib(Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose)
- Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 19 months)
- Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)(Up to approximately 19 months)
研究者
研究点 (5)
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