Safety and Pharmacokinetics of Tucatinib (MK-7119) in Chinese Participants With Cancer (MK-7119-002)

Phase 1Active Not RecruitingNCT05382364

Pfizer25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic HER2+ Advanced Breast Cancer Breast Neoplasms Gastric or Gastroesophageal Junction Adenocarcinoma (GEC)Colorectal Cancer

Interventions

TucatinibDRUG

Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jilin Cancer Hospital

Changchun, Jilin, China

Fudan University Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

Percentage of participants with ≥1 adverse event (AE)

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.

Time frame: Up to approximately 2.5 years

Percentage of participants discontinuing from study therapy due to AE

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.

Time frame: Up to approximately 2.5 years

Secondary Outcomes

Maximum plasma concentration (Cmax) of first dose of tucatinib

The Cmax of tucatinib will be determined after the first dose.

Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Time of maximum plasma concentration (Tmax) of first dose of tucatinib

The Tmax of tucatinib will be determined after the first dose.

Time frame: 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

The AUC0-12 of tucatinib will be determined after the first dose.

Time frame: 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

The t½ of tucatinib will be determined after the first dose.

Time frame: Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose

Data from ClinicalTrials.gov

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