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NCT01103323 · ClinicalTrials.gov registry record · Phase 3
Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 760
- Enrollment target
NCT01103323: Completed Phase 3 study, sponsored by Bayer.
NCT01103323 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 760 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01103323, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 760 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
Primary Outcome
Overall survival (OS) was defined as the time (days) from randomization to death due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive. If a patient was lost to follow-up and there was no contact after randomization, this patient was censored at Day 1.
Interventions
- DRUG Placebo
- OTHER Best Supportive Care (BSC)
- DRUG Regorafenib (Stivarga, BAY73-4506)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 760 participants |
| Start Date | 2010-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01103323 record still lists
NCT01103323 is an interventional study that assigns participants to a tested intervention. The registered 760 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01103323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01103323 about?
NCT01103323 is a clinical study titled "Patients With Metastatic Colorectal Cancer Treated With Regorafenib or Placebo After Failure of Standard Therapy". This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
What is the current status of trial NCT01103323?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 760 participants. The study started on 2010-04. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01103323?
The interventions under investigation include: Placebo (DRUG), Best Supportive Care (BSC) (OTHER), Regorafenib (Stivarga, BAY73-4506) (DRUG).
Who is sponsoring clinical trial NCT01103323?
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 NCT01103323's enrollment target sits among peer trials
760 450th of 2000 higher than 1,546 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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