Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT01298570 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UNC Lineberger Comprehensive Cancer Center, which has 374 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01298570 reports 20 study locations spanning 8 distinct geographic areas — top geographies include North Carolina, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01298570?

The interventions under investigation include: Placebo (DRUG), FOLFIRI (DRUG), Regorafenib (BAY 73-4506) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01298570?

This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 374 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial