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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
United States
for more information at clinicaltrials.gov
EXPERIMENTAL: Single Arm
Tucatinib + trastuzumab deruxtecan
DRUG: tucatinib
300 mg orally twice daily
DRUG: trastuzumab deruxtecan
5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle
Inclusion Criteria
Confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 according to investigator assessment
ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) per RECIST v1.1
From start of treatment up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 according to investigator assessment
DOR is defined as the time from first documentation of objective response to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs earlier
From start of treatment up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 according to investigator assessment
PFS is defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever comes first
From start of treatment up to approximately 3 years
Disease control rate (DCR) per RECIST v1.1 according to investigator assessment
DCR is defined as the proportion of subjects with confirmed CR, PR or stable disease according to RECIST v1.1
From start of treatment up to approximately 3 years
Overall survival (OS)
OS is defined as the time from treatment initiation to death due to any cause
From start of treatment up to approximately 5 years
Incidence of adverse events (AEs)
An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
From start of treatment up to approximately 3 years
Incidence of laboratory abnormalities
From start of treatment up to approximately 3 years
Incidence of dose modifications
From start of treatment up to approximately 3 years
Incidence of treatment discontinuations
From start of treatment up to approximately 3 years
70
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: