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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05382364
• Other study ID #: 7119-002
• Secondary ID: MK-7119-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 29, 2022
• Est. completion date: December 29, 2025

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 29, 2025
• Est. primary completion date: January 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Jilin Cancer Hospital-oncology department ( Site 0007)	Changchun	Jilin
China	Hunan Cancer Hospital-Digestion and Urology ( Site 0008)	Changsha	Hunan
China	Harbin Medical University Cancer Hospital-oncology of department ( Site 0010)	Harbin	Heilongjiang
China	Fudan University Shanghai Cancer Center-Oncology ( Site 0001)	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute and Hospital-Gastric oncology ( Site 0005)	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to approximately 2.5 years
Primary	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.	Up to approximately 2.5 years
Secondary	Maximum plasma concentration (Cmax) of first dose of tucatinib	The Cmax of tucatinib will be determined after the first dose.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Time of maximum plasma concentration (Tmax) of first dose of tucatinib	The Tmax of tucatinib will be determined after the first dose.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	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.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Apparent plasma half-life (t½) of first dose of tucatinib	The t½ of tucatinib will be determined after the first dose.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Apparent clearance (CL/F) of first dose of tucatinib	The CL/F of tucatinib will be determined after the first dose.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Volume of distribution (Vz/F) of first dose of tucatinib	The Vz/F of tucatinib will be determined after the first dose.	Cycle 1, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Trough concentration (Ctrough) of tucatinib at steady state	The Ctrough of tucatinib will be determined at steady state.	Cycle 1, Days 8 and 15: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Accumulation ratio of tucatinib at steady state	The accumulation ratio of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Cmax at steady state (Cmaxss) of tucatinib	The Cmaxss of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Tmax at steady state (Tmaxss) of tucatinib	The Tmaxss of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	AUC0-12 at steady state (AUC0-12ss) of tucatinib	The AUC0-12ss of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	t½ of tucatinib at steady state	The t½ of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	CL/F at steady state (CL/Fss) of tucatinib	The CL/Fss of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Vz/F at steady state (Vz/Fss) of tucatinib	The Vz/Fss of tucatinib will be determined at steady state.	Cycle 2, Day 1: predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose
Secondary	Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	ORR is defined as the percentage of participants who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR based on RECIST 1.1 will be presented.	Up to approximately 19 months
Secondary	Duration of Response (DOR) Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)	For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.	Up to approximately 19 months

External Links

•   Merck Oncology Clinical Trials Information