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NCT02149108 · ClinicalTrials.gov registry record · Phase 3
Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 768
- Enrollment target
NCT02149108: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT02149108 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 768 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
NCT02149108, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 768 participants
- Enrollment target
Study Summary
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
Primary Outcome
PFS by central review assessment was defined as the time from the date of randomisation to the date of disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 or death from any cause, whichever occurred first. Median, 95% Confidence Interval were calculated from an unadjusted Kaplan-Meier curve for each treatment arm.
Interventions
- DRUG Placebo
- DRUG BSC
- DRUG Nintedanib (BIBF 1120)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 768 participants |
| Start Date | 2014-09-25 |
| Est. Completion | 2016-08-25 |
| Phase | Phase 3 |
What the finished NCT02149108 record still lists
NCT02149108 is an interventional study that assigns participants to a tested intervention. The registered 768 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.
NCT02149108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02149108 about?
NCT02149108 is a clinical study titled "Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)". The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
What is the current status of trial NCT02149108?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 768 participants. The study started on 2014-09-25. Estimated completion is 2016-08-25.
What interventions are being tested in trial NCT02149108?
The interventions under investigation include: Placebo (DRUG), BSC (DRUG), Nintedanib (BIBF 1120) (DRUG).
Who is sponsoring clinical trial NCT02149108?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02149108's enrollment target sits among peer trials
768 445th of 2000 higher than 1,556 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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