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NCT04117945 · ClinicalTrials.gov registry record · Phase 2
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
A Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, sponsored by Academic and Community Cancer Research United.
- Active
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
- 15
- Study locations
NCT04117945 is a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8 that is active but no longer recruiting, run by Academic and Community Cancer Research United. The registered enrollment target is 22 participants, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 15 study locations across 14 states.
The verdict
NCT04117945, a Phase 2 study of Stage IV Colorectal Cancer AJCC v8 and Stage III Colorectal Cancer AJCC v8, is active but no longer recruiting, sponsored by Academic and Community Cancer Research United.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
- 15
- Study locations
Study Summary
This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic). Regorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab or panitumumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The purpose of this research study is to compare the effects, good and/or bad, of taking regorafenib follow by cetuximab or panitumumab, to those that receive cetuximab or panitumumab before regorafenib.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Regorafenib
- DRUG Irinotecan
- BIOLOGICAL Panitumumab
Study Locations (15)
Iowa
- University of Iowa/Holden Comprehensive Cancer Center - Iowa City
- Siouxland Regional Cancer Center - Sioux City
Arizona
- Mayo Clinic in Arizona - Scottsdale
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Mayo Clinic in Florida - Jacksonville
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Kansas
- Cancer Center of Kansas - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-03-03 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04117945
The ClinicalTrials.gov registry entry for NCT04117945 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 22 other Stage IV Colorectal Cancer AJCC v8 trials with a reported enrollment target (80% lower). The listed sponsor is Academic and Community Cancer Research United, which has 42 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Stage IV Colorectal Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Cetuximab is the first listed.
NCT04117945 reports 15 study locations spanning 14 distinct geographic areas - top geographies include Iowa, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04117945 about?
NCT04117945 is a clinical study titled "Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer". This phase II trial how well regorafenib and anti-EGFR therapy (cetuximab or panitumumab) works for the treatment of patients with colorectal cancer that cannot be removed by surgery (unresectable), has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the b...
What is the current status of trial NCT04117945?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2020-03-03. Estimated completion is 2025-03-31.
What conditions does trial NCT04117945 study?
This clinical trial studies the following conditions: Stage IV Colorectal Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8.
What interventions are being tested in trial NCT04117945?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Regorafenib (DRUG), Irinotecan (DRUG), Panitumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04117945?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04117945 being conducted?
This trial has 15 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.