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NCT01298570 · ClinicalTrials.gov registry record · Phase 2
Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer
A Phase 2 study of Colorectal Cancer Metastatic, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
- 20
- Study locations
NCT01298570 is a Phase 2 study of Colorectal Cancer Metastatic that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 181 participants, roughly in line with the 195-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target. The trial reports 20 study locations across 8 states.
The verdict
NCT01298570, a Phase 2 study of Colorectal Cancer Metastatic, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG FOLFIRI
- DRUG Regorafenib (BAY 73-4506)
Study Locations (20)
North Carolina
- Seby B. Jones Cancer Center - Boone
- University of North Carolina - Chapel Hill
- Carolinas HealthCare System - Charlotte
- Southeast Medical Oncology Center - Goldsboro
- The Moses Cone Regional Cancer Center - Greensboro
- Leo W. Jenkins Cancer Center at ECU Medical School - Greenville
- First Health of the Carolinas, Moore Regional Hospital - Pinehurst
- Rex Cancer Center at Rex Hospital - Raleigh
- Wake Forest University Comprehensive Cancer Center - Winston-Salem
Florida
- Mount Sinai Medical Center-Miami - Miami
- Moffitt Cancer Center - Tampa
Georgia
- Emory University - Atlanta
- Georgia Cancer Specialists - Atlanta
New York
- North Shore Long Island Jewish Health System - Manhasset
- New York University Langone Medical Center - New York
Ohio
- University of Cincinnati - Cincinnati
- Ohio State University Comprehensive Cancer Center - Columbus
Colorado
- Rocky Mountain Cancer Centers - Denver
Indiana
- Indiana University Simon Cancer Center - Indianapolis
Kentucky
- University of Louisville James Brown Cancer Center - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2011-04-07 |
| Est. Completion | 2020-10-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01298570
The ClinicalTrials.gov registry entry for NCT01298570 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 195-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 366 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colorectal Cancer Metastatic appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01298570 reports 20 study locations spanning 8 distinct geographic areas - top geographies include North Carolina, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01298570 about?
NCT01298570 is a clinical study titled "Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer". This randomized (2:1), multi-center, placebo-controlled, phase II efficacy study is designed to compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients with mCRC previously treated with a FOLFOX regimen.
What is the current status of trial NCT01298570?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2011-04-07. Estimated completion is 2020-10-02.
What conditions does trial NCT01298570 study?
This clinical trial studies the following conditions: Colorectal Cancer Metastatic.
What interventions are being tested in trial NCT01298570?
The interventions under investigation include: Placebo (DRUG), FOLFIRI (DRUG), Regorafenib (BAY 73-4506) (DRUG).
Who is sponsoring clinical trial NCT01298570?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01298570 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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.