Clinical trial NCT05382364: Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Metastatic HER2+ Advanced Breast Cancer
Breast Neoplasms
Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)
Colorectal Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-05-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of participants with ≥1 adverse event (AE)
timeFrame: Up to approximately 2.5 years
measure: Percentage of participants discontinuing from study therapy due to AE
timeFrame: Up to approximately 2.5 years
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Time of maximum plasma concentration (Tmax) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Area under the plasma concentration time curve from dosing to 12 hours postdose (AUC0-12) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Apparent plasma half-life (t½) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Apparent clearance (CL/F) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Volume of distribution (Vz/F) of first dose of tucatinib
timeFrame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Trough concentration (Ctrough) of tucatinib at steady state
timeFrame: Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Accumulation ratio of tucatinib at steady state
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Cmax at steady state (Cmaxss) of tucatinib
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Tmax at steady state (Tmaxss) of tucatinib
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: AUC0-12 at steady state (AUC0-12ss) of tucatinib
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: t½ of tucatinib at steady state
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: CL/F at steady state (CL/Fss) of tucatinib
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Vz/F at steady state (Vz/Fss) of tucatinib
timeFrame: Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
measure: Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 19 months
measure: Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: Up to approximately 19 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-oncology of department ( Site 0010)
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Cancer Hospital-Digestion and Urology ( Site 0008)
state: Hunan
city: Changchun
country: China
facility: Jilin Cancer Hospital-oncology department ( Site 0007)
state: Jilin
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Oncology ( Site 0001)
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0005)
state: Tianjin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: