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NCT01907100 · ClinicalTrials.gov registry record · Phase 2
Nintedanib (BIBF 1120) in Mesothelioma
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 545
- Enrollment target
NCT01907100: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT01907100 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 545 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (310% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01907100, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 545 participants
- Enrollment target
Study Summary
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
Primary Outcome
This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2013-09-19 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 2 |
Why NCT01907100 stopped before completion
NCT01907100 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (310% higher).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT01907100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01907100 about?
NCT01907100 is a clinical study titled "Nintedanib (BIBF 1120) in Mesothelioma". This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable ma...
What is the current status of trial NCT01907100?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 545 participants. The study started on 2013-09-19. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT01907100?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT01907100?
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 NCT01907100's enrollment target sits among peer trials
545 62nd of 2000 higher than 1,939 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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