Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
First Line Treatment of Metastatic Colorectal Cancer With mFOLFOX6 in Combination With Regorafenib
NCT01289821 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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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. 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 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 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 Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Oxaliplatin 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: NCT01289821 reports 18 study locations spanning 15 distinct geographic areas — top geographies include Other, Illinois, New South Wales. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01289821?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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