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NCT01289821 · ClinicalTrials.gov registry record · Phase 2

First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib

A Phase 2 study of Colorectal Neoplasms, sponsored by Bayer.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
18
Study locations

NCT01289821 is a Phase 2 study of Colorectal Neoplasms that has completed, run by Bayer. The registered enrollment target is 54 participants, below the 576-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (91% lower). The trial reports 18 study locations across 15 states.

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The verdict

NCT01289821, a Phase 2 study of Colorectal Neoplasms, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
18
Study locations

Study Summary

This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy of colorectal cancer with mFOLFOX6 in combination with regorafenib improves the response rate observed for the standard therapy only.

Conditions Studied

Colorectal Neoplasms

Interventions

  • DRUG Oxaliplatin
  • DRUG Regorafenib (Stivarga, BAY73-4506)
  • DRUG Folinic acid
  • DRUG 5-FU (mFOLFOX6)

Study Locations (18)

Other

  • - Bruxelles - Brussel
  • - Edegem
  • - Leuven
  • - Glasgow

Illinois

  • - Chicago

New South Wales

  • - Concord

South Australia

  • - Woodville South

Baden-Wurttemberg

  • - Stuttgart

Lower Saxony

  • - Oldenburg

North Rhine-Westphalia

  • - Herne

Saxony

  • - Dresden

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2011-02
Est. Completion 2014-06
Phase Phase 2

Sponsor

Bayer

591 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01289821

The ClinicalTrials.gov registry entry for NCT01289821 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 576-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (91% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colorectal Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Oxaliplatin is the first listed.

NCT01289821 reports 18 study locations spanning 15 distinct geographic areas - top geographies include Other, Illinois, New South Wales.

Frequently Asked Questions

What is clinical trial NCT01289821 about?

NCT01289821 is a clinical study titled "First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib". This is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mFOLFOX6 as first line therapy in patients with metastatic colorectal cancer (CRC). mFOLFOX6 is an approved chemotherapy. Regorafenib is an oral (i.e. taken by mouth) mu...

What is the current status of trial NCT01289821?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2011-02. Estimated completion is 2014-06.

What conditions does trial NCT01289821 study?

This clinical trial studies the following conditions: Colorectal Neoplasms.

What interventions are being tested in trial NCT01289821?

The interventions under investigation include: Oxaliplatin (DRUG), Regorafenib (Stivarga, BAY73-4506) (DRUG), Folinic acid (DRUG), 5-FU (mFOLFOX6) (DRUG).

Who is sponsoring clinical trial NCT01289821?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01289821 being conducted?

This trial has 18 study locations across Illinois, New South Wales, South Australia, Baden-Wurttemberg, Lower Saxony. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.