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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: Completed Phase 2 study of Colorectal Neoplasms, sponsored by Bayer.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
OR was defined as the best tumor response (confirmed complete response \[CR\] or partial response \[PR\]) observed by MRI or CT scan assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. CR and PR were confirmed not earlier than 4 weeks following the initial detection of response. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). Any pathological lymph nodes (whether target or non target) must have
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 |
What the finished NCT01289821 record still lists
NCT01289821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 576-participant average among 54 other Colorectal Neoplasms trials with a reported enrollment target (91% lower).
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 lists 18 locations in 15 states (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.
Learn More About Clinical Trials
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Where NCT01289821's enrollment target sits among peer trials
54 45th of 54 higher than 10 of 54 other Colorectal Neoplasms trials
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Each bar is a band; taller bars hold more other Colorectal Neoplasms 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.
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