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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: Completed Phase 2 study of Colorectal Cancer Metastatic, sponsored by UNC Lineberger Comprehensive Cancer Center.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

To compare PFS between regorafenib + FOLFIRI chemotherapy (ARM A) versus placebo + FOLFIRI (ARM B) in patients failing one prior oxaliplatin-containing regimen for metastatic colorectal cancer. PFS is defined as the time from randomization until metastatic colorectal cancer (mCRC) progression or death as a result of any cause. Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disapp

Conditions Studied

Colorectal Cancer Metastatic

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

FieldValue
Enrollment Target 181 participants
Start Date 2011-04-07
Est. Completion 2020-10-02
Phase Phase 2
UNC Lineberger Comprehensive Cancer Center

366 total trials

What the finished NCT01298570 record still lists

NCT01298570 is an interventional study that assigns participants to a tested intervention. The registered 181 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 195-participant average among 18 other Colorectal Cancer Metastatic trials with a reported enrollment target.

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 names 20 study sites across 8 states, led by 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.

Learn More About Clinical Trials

Similar trials for Colorectal Cancer Metastatic

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 NCT01298570's enrollment target sits among peer trials

181 2nd of 18 the highest of 18 other Colorectal Cancer Metastatic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Colorectal Cancer Metastatic 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01298570, the US trial registry maintained by the National Library of Medicine. NCT01298570 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.