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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: Recruiting Phase 3 study of Colorectal Neoplasms, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
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 |
What NCT05253651 shows while recruiting
NCT05253651 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 569-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (30% lower).
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 names 20 study sites across 2 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05253651's enrollment target sits among peer trials
400 18th of 54 higher than 36 of 54 other Colorectal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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