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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05253651
Registration number
NCT05253651
Ethics application status
Date submitted
14/02/2022
Date registered
24/02/2022
Date last updated
25/06/2024
Titles & IDs
Public title
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
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Scientific title
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
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Secondary ID [1]
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2021-002672-40
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Secondary ID [2]
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SGNTUC-029
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Universal Trial Number (UTN)
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Trial acronym
MOUNTAINEER-03
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tucatinib
Treatment: Drugs - trastuzumab
Treatment: Drugs - bevacizumab
Treatment: Drugs - cetuximab
Treatment: Drugs - oxaliplatin
Treatment: Drugs - leucovorin
Treatment: Drugs - levoleucovorin
Treatment: Drugs - fluorouracil
Experimental: Tucatinib Arm - Tucatinib + trastuzumab + mFOLFOX6
Active comparator: Standard of Care Arm - mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab
Treatment: Drugs: tucatinib
300mg given by mouth (orally) twice daily
Treatment: Drugs: 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.
Treatment: Drugs: bevacizumab
5mg/kg given by IV every 2 weeks
Treatment: Drugs: cetuximab
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
Treatment: Drugs: oxaliplatin
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
Treatment: Drugs: leucovorin
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
Treatment: Drugs: levoleucovorin
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
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Assessment method [1]
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The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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The time from randomization to death from any cause
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Timepoint [1]
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Up to approximately 6 years
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Secondary outcome [2]
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Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
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Assessment method [2]
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The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by BICR
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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PFS per RECIST v1.1 by investigator assessment
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Assessment method [3]
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The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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cORR per RECIST v1.1 by investigator assessment
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Assessment method [4]
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The proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Duration of response (DOR) per RECIST v1.1 by BICR
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Assessment method [5]
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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
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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DOR per RECIST v1.1 by investigator assessment
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Assessment method [6]
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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
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Timepoint [6]
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Up to approximately 3 years
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Secondary outcome [7]
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Time to second progression or death (PFS2)
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Assessment method [7]
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The time from randomization to disease progression on the next-line of therapy, or death from any cause
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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Incidence of adverse events (AEs)
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Assessment method [8]
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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.
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Timepoint [8]
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Through 30 days after the last study treatment; approximately 1 year
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Secondary outcome [9]
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Incidence of dose alterations
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Assessment method [9]
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Timepoint [9]
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Through 30 days after the last study treatment; approximately 1 year
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Secondary outcome [10]
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Trough concentration (Ctrough)
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Assessment method [10]
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PK parameter
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Timepoint [10]
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Approximately 4 months
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Secondary outcome [11]
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Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
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Assessment method [11]
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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.
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Timepoint [11]
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Through 30-37 days after the last study treatment; approximately 1 year
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Secondary outcome [12]
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Time to meaningful change in EORTC QLQ30 score
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Assessment method [12]
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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.
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Timepoint [12]
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Through 30-37 days after the last study treatment; approximately 1 year
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Eligibility
Key inclusion criteria
* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
* Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
* If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
* HER2+ disease as determined by a tissue based assay performed at a central laboratory.
* Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
* Radiographically measurable disease per RECIST v1.1 with:
* At least one site of disease that is measurable and that has not been previously irradiated, or
* If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
* No evidence of brain metastases
* Previously treated brain metastases which are asymptomatic
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
* Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
* Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
* Previous treatment with anti-HER2 therapy
* Ongoing Grade 3 or higher neuropathy
* GI perforation within 12 months of enrollment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/10/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2028
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
Othe
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Recruitment hospital [1]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Townsville Cancer Center - Townsville
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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4814 - Townsville
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Recruitment outside Australia
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Arizona
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California
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Colorado
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Florida
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Georgia
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Kansas
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Kentucky
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Minnesota
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New York
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North Carolina
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Ohio
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Tennessee
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Texas
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Argentina
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Austria
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Belgium
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France
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Ireland
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Dublin
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Italy
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Italy
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Firenze
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Japan
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Portugal
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United Kingdom
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:
* mFOLFOX6 alone,
* mFOLFOX6 with bevacizumab, or
* mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
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Trial website
https://clinicaltrials.gov/study/NCT05253651
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Monitor
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Address
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Seagen Inc.
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Contact person for public queries
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Seagen Trial Information Support
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Address
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Phone
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866-333-7436
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05253651
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