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Completed Phase 2 Interventional Results available

Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer

ClinicalTrials.gov ID: NCT01298570

Public ClinicalTrials.gov record NCT01298570. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI Versus Placebo With FOLFIRI as Second-Line Therapy in Patients With Metastatic Colorectal Cancer

Study identification

NCT ID
NCT01298570
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Other
Enrollment
181 participants

Conditions and interventions

Interventions

  • Regorafenib (BAY 73-4506) Drug
  • FOLFIRI Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 6, 2011
Primary completion
Nov 14, 2016
Completion
Oct 1, 2020
Last update posted
Jan 5, 2021

2011 – 2020

United States locations

U.S. sites
23
U.S. states
10
U.S. cities
22
Facility City State ZIP Site status
Rocky Mountain Cancer Centers Denver Colorado 80218
Mount Sinai Medical Center-Miami Miami Florida 33140
Moffitt Cancer Center Tampa Florida 33612
Emory University Atlanta Georgia 30322
Georgia Cancer Specialists Atlanta Georgia 30341
Indiana University Simon Cancer Center Indianapolis Indiana 46202
University of Louisville James Brown Cancer Center Louisville Kentucky 40202
North Shore Long Island Jewish Health System Manhasset New York 11030
New York University Langone Medical Center New York New York 10016
Seby B. Jones Cancer Center Boone North Carolina 28607
University of North Carolina Chapel Hill North Carolina 27599
Carolinas HealthCare System Charlotte North Carolina 28262
Southeast Medical Oncology Center Goldsboro North Carolina 27534
The Moses Cone Regional Cancer Center Greensboro North Carolina 27403
Leo W. Jenkins Cancer Center at ECU Medical School Greenville North Carolina 27834
First Health of the Carolinas, Moore Regional Hospital Pinehurst North Carolina 28374
Rex Cancer Center at Rex Hospital Raleigh North Carolina 27607
Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina 27157-1096
University of Cincinnati Cincinnati Ohio 45267
Ohio State University Comprehensive Cancer Center Columbus Ohio 43221
University of Virginia Charlottesville Virginia 22903
Portsmouth Naval Medical Center Portsmouth Virginia 23708
Multicare Regional Cancer Center Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01298570, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 5, 2021 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01298570 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →