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NCT05253651 · ClinicalTrials.gov registry record · Phase 3
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
A Phase 3 study of Colorectal Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT05253651 is a Phase 3 study of Colorectal Neoplasms that is actively recruiting participants, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 400 participants, below the 569-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 2 states.
The verdict
NCT05253651, a Phase 3 study of Colorectal Neoplasms, is actively recruiting participants, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Conditions Studied
Interventions
- DRUG cetuximab
- DRUG bevacizumab
- DRUG tucatinib
- DRUG trastuzumab
- DRUG oxaliplatin
Study Locations (20)
California
- Los Angeles Cancer Network - Anaheim - Anaheim
- Kaiser Permanente Anaheim Kraemer Medical Offices - Anaheim
- Kaiser Permanente Baldwin Park Medical Center - Baldwin Park
- Kaiser Permanente Bellflower Medical Offices - Bellflower
- Kaiser Permanente Fontana Medical Center - Fontana
- Los Angeles Cancer Network - Fountain Vally - Fountain Valley
- Los Angeles Hematology Oncology Medical Group - Glendale
- Los Angeles Hematology Oncology Medical Group - Glendale
- Kaiser Permanente South Bay Medical center - Harbor City
- Kaiser Permanente Alton/Sand Canyon Medical Offices - Irvine
- Los Angeles Hematology Oncology Medical Group - Los Angeles
- USC Norris Koreatown - Medical Oncology - Los Angeles
- Kaiser Permanente Los Angeles Medical Offices - Los Angeles
- Keck Hospital of USC - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- University of Southern California - Los Angeles
Arizona
- Palo Verde Hematology Oncology - Glendale
- Mayo Clinic Building - Phoenix - Phoenix
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2029-07-27 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05253651
The ClinicalTrials.gov registry entry for NCT05253651 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 569-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (30% lower). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which cetuximab is the first listed.
NCT05253651 reports 20 study locations spanning 2 distinct geographic areas - top geographies include California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05253651 about?
NCT05253651 is a clinical study titled "A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer". 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...
What is the current status of trial NCT05253651?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2022-10-24. Estimated completion is 2029-07-27.
What conditions does trial NCT05253651 study?
This clinical trial studies the following conditions: Colorectal Neoplasms.
What interventions are being tested in trial NCT05253651?
The interventions under investigation include: cetuximab (DRUG), bevacizumab (DRUG), tucatinib (DRUG), trastuzumab (DRUG), oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT05253651?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05253651 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.