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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

Titles & IDs
Public title
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
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
Secondary ID [1] 0 0
C4251008
Secondary ID [2] 0 0
SGNTUC-029
Universal Trial Number (UTN)
Trial acronym
MOUNTAINEER-03
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
Up to approximately 6 years
Secondary outcome [2] 0 0
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
PFS per RECIST v1.1 by investigator assessment
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
cORR per RECIST v1.1 by investigator assessment
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Duration of response (DOR) per RECIST v1.1 by BICR
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
DOR per RECIST v1.1 by investigator assessment
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Time to second progression or death (PFS2)
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Incidence of adverse events (AEs)
Timepoint [8] 0 0
Through 30 days after the last study treatment; approximately 1 year
Secondary outcome [9] 0 0
Incidence of dose alterations
Timepoint [9] 0 0
Through 30 days after the last study treatment; approximately 1 year
Secondary outcome [10] 0 0
Trough concentration (Ctrough)
Timepoint [10] 0 0
Approximately 4 months
Secondary outcome [11] 0 0
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Timepoint [11] 0 0
Through 30-37 days after the last study treatment; approximately 1 year
Secondary outcome [12] 0 0
Time to meaningful change in EORTC QLQ30 score
Timepoint [12] 0 0
Through 30-37 days after the last study treatment; approximately 1 year

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or 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
* Active or untreated gastrointestinal (GI) perforation at the time of screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/07/2029
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Townsville Hospital and Health Service - Townsville
Recruitment hospital [2] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
4814 - Townsville
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment outside Australia
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Switzerland
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Schlieren
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Winterthur
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England
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Manchester
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen, a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
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Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05253651