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NCT01939223 · ClinicalTrials.gov registry record · Phase 3
Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 25
- Enrollment target
NCT01939223: Clinical Trial Phase 3 study, sponsored by Bayer.
NCT01939223 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01939223, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 25 participants
- Enrollment target
Study Summary
To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.
Primary Outcome
Disease free survival was evaluated by CT / MRI scans as assessed by the investigator, which was defined as the time (in days) from date of randomization to date of first observed radiographic disease recurrence (RECIST 1.1 criteria for measurable and non-measurable disease) or death due to any cause, if death occurred before disease recurrence was documented. For subjects without documented disease recurrence or death at the time of analysis, the DFS time was censored at the date of the last ev
Interventions
- DRUG Placebo
- DRUG Regorafenib (Stivarga, BAY73-4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2013-12-02 |
| Est. Completion | 2016-08-29 |
| Phase | Phase 3 |
Why NCT01939223 stopped before completion
NCT01939223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01939223 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01939223 about?
NCT01939223 is a clinical study titled "Colorectal Cancer Treated With Adjuvant Regorafenib Versus Placebo After Curative Treatment of Liver Metastases in a Randomized, Double-blind, Placebo-Controlled Phase-III STudy". To evaluate and compare the efficacy and safety of regorafenib versus placebo in subjects with colorectal cancer (CRC) after curative resection of liver metastasis and completion of all planned chemotherapy.
What is the current status of trial NCT01939223?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2013-12-02. Estimated completion is 2016-08-29.
What interventions are being tested in trial NCT01939223?
The interventions under investigation include: Placebo (DRUG), Regorafenib (Stivarga, BAY73-4506) (DRUG).
Who is sponsoring clinical trial NCT01939223?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01939223's enrollment target sits among peer trials
25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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