The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
China
EXPERIMENTAL: Tucatinib Treatment
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.
DRUG: Tucatinib
Tucatinib 150 mg and 50 mg tablets taken by mouth at a dose of 300 mg twice daily.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT05382364
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