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Pfizer CT.gov Call Center 1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com


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Be Part of Research - Trial Details - A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
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A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Recruiting

Open to: ALL

Age: 18.0 - N/A

Cambridge Manchester Bristol Cottingham Leeds London London London Glasgow Surrey Newcastle upon Tyne

Medical Conditions

Colorectal Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 determine 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2022 Apr 2026

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : 300mg given by mouth (orally) twice daily

Intervention Arm Group : Tucatinib Arm;

Intervention Type : DRUG
Intervention Description : 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.

Intervention Arm Group : Tucatinib Arm;

Intervention Type : DRUG
Intervention Description : 5mg/kg given by IV every 2 weeks

Intervention Arm Group : Standard of Care Arm;

Intervention Type : DRUG
Intervention Description : 400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly

Intervention Arm Group : Standard of Care Arm;

Intervention Type : DRUG
Intervention Description : 85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

Intervention Arm Group : Standard of Care Arm;Tucatinib Arm;

Intervention Type : DRUG
Intervention Description : 400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

Intervention Arm Group : Standard of Care Arm;Tucatinib Arm;

Intervention Type : DRUG
Intervention Description : 200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

Intervention Arm Group : Standard of Care Arm;Tucatinib Arm;

Intervention Type : DRUG
Intervention Description : 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 Arm Group : Standard of Care Arm;Tucatinib Arm;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cambridge University Hospitals NHS Foundation Trust
    Cambridge
    Other
    CB2 0QQ
  • The Christie NHS Foundation Trust
    Manchester
    Other
    M20 4BX
  • University Hospitals Bristol and Weston NHS Foundation Trust
    Bristol
    Other
    BS2 8ED
  • Hull University Teaching Hospitals NHS Trust
    Cottingham
    Other
    HU16 5JQ
  • Leeds Teaching Hospitals Trust
    Leeds
    Other
    LS9 7TF
  • Guy's and St Thomas' NHS Foundation
    London
    Other
    SE1 9RT
  • Imperial College Healthcare NHS Trust
    London
    Other
    W12 0HS
  • The Royal Marsden NHS Foundation Trust (RM)
    London
    Other
    SW3 6JJ
  • The Beatson West of Scotland Cancer Centre
    Glasgow
    Other
    G12 0YN
  • The Royal Marsden NHS Foundation Trust (RM)
    Surrey
    Other
    SM2 5PT
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle upon Tyne
    Other
    NE7 7DN

Pfizer CT.gov Call Center 1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com



The study is sponsored by Seagen Inc.



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Read full details for Trial ID: NCT05253651
Last updated 19 February 2025

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