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 enrolling
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Greece, Hungary, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Slovakia, Spain, Switzerland, Taiwan, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Tucatinib Arm
Tucatinib + trastuzumab + mFOLFOX6
DRUG: tucatinib
300mg given by mouth (orally) twice dailyDRUG: trastuzumab
8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.DRUG: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.DRUG: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.DRUG: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.DRUG: fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.ACTIVE_COMPARATOR: Standard of Care Arm
mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
DRUG: bevacizumab
5mg/kg given by IV every 2 weeksDRUG: cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weeklyDRUG: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.DRUG: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.DRUG: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.DRUG: fluorouracil
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years
Overall survival (OS)
The time from randomization to death from any cause
Up to approximately 6 years
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by BICR
Up to approximately 3 years
PFS per RECIST v1.1 by investigator assessment
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Up to approximately 3 years
cORR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators
Up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 by BICR
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Up to approximately 3 years
DOR per RECIST v1.1 by investigator assessment
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Up to approximately 3 years
Time to second progression or death (PFS2)
The time from randomization to disease progression on the next-line of therapy, or death from any cause
Up to approximately 3 years
Incidence of adverse events (AEs)
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.
Through 30 days after the last study treatment; approximately 1 year
Incidence of dose alterations
Through 30 days after the last study treatment; approximately 1 year
Trough concentration (Ctrough)
PK parameter
Approximately 4 months
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/quality of life (QoL) scales, higher scores indicate better functioning or global health status/quality of life (QoL). For symptom scales, higher scores indicate greater symptom burden.
Through 30-37 days after the last study treatment; approximately 1 year
Time to meaningful change in EORTC QLQ30 score
The time from baseline to the first onset of a ≥10-point changes in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Through 30-37 days after the last study treatment; approximately 1 year
400
Sponsor: Seagen Inc.
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.
NCT05253651
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