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NCT03317119 · ClinicalTrials.gov registry record · Phase 1
Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery
A Phase 1 study of Metastatic Colorectal Carcinoma and Metastatic Colon Carcinoma, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 8
- Study locations
NCT03317119 is a Phase 1 study of Metastatic Colorectal Carcinoma and Metastatic Colon Carcinoma that has completed, run by City of Hope Medical Center. The registered enrollment target is 26 participants, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (70% lower). The trial reports 8 study locations across 1 state.
The verdict
NCT03317119, a Phase 1 study of Metastatic Colorectal Carcinoma and Metastatic Colon Carcinoma, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as trifluridine and tipiracil hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving trametinib and trifluridine and tipiracil hydrochloride may prevent cancer cells from dividing and work better in treating patients with colon and rectal cancer.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Trametinib
- DRUG Trifluridine and Tipiracil Hydrochloride
Study Locations (8)
California
- City of Hope Corona - Corona
- City of Hope Medical Center - Duarte
- City of Hope Antelope Valley - Lancaster
- City of Hope Mission Hills - Mission Hills
- City of Hope Rancho Cucamonga - Rancho Cucamonga
- City of Hope - Santa Clarita - Santa Clarita
- City of Hope South Pasadena - South Pasadena
- City of Hope West Covina - West Covina
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-04-11 |
| Est. Completion | 2023-07-14 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03317119
The ClinicalTrials.gov registry entry for NCT03317119 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 22 other Metastatic Colorectal Carcinoma trials with a reported enrollment target (70% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Metastatic Colorectal Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03317119 reports 8 study locations spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT03317119 about?
NCT03317119 is a clinical study titled "Trametinib and Trifluridine and Tipiracil Hydrochloride in Treating Patients With Colon or Rectal Cancer That is Advanced, Metastatic, or Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of trametinib and trifluridine and tipiracil hydrochloride in treating patients with colon or rectal cancer that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery. Trametinib may stop the growth of t...
What is the current status of trial NCT03317119?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-04-11. Estimated completion is 2023-07-14.
What conditions does trial NCT03317119 study?
This clinical trial studies the following conditions: Metastatic Colorectal Carcinoma, Metastatic Colon Carcinoma, Stage III Colon Cancer AJCC v7, Stage IIIA Colorectal Cancer AJCC v7, Stage IIIA Rectal Cancer AJCC v7.
What interventions are being tested in trial NCT03317119?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Trametinib (DRUG), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT03317119?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03317119 being conducted?
This trial has 8 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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