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NCT02240706 · ClinicalTrials.gov registry record · Phase 2
Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02240706: Clinical Trial Phase 2 study, sponsored by Boehringer Ingelheim.
NCT02240706 is a Phase 2 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02240706, a Phase 2 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia.
Primary Outcome
The MTD is defined as the highest dose of BI 836858 with less than 25% risk of the true dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period. MTD determination will be based on a Bayesian logistic regression model with overdose control. For any dose-escalation cohort, at least 3 patients (pts) will be required. However, in the case that only 2 pts are evaluable and neither has experienced a DLT within the first cycle (2 administrations - 28 days), then dose-escalat
Interventions
- DRUG BI 836858
- PROCEDURE Best Supportive Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-01-22 |
| Est. Completion | 2019-11-18 |
| Phase | Phase 2 |
Why NCT02240706 stopped before completion
NCT02240706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 2 interventions - of which BI 836858 is the first listed.
NCT02240706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02240706 about?
NCT02240706 is a clinical study titled "Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes". Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and effica...
What is the current status of trial NCT02240706?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2015-01-22. Estimated completion is 2019-11-18.
What interventions are being tested in trial NCT02240706?
The interventions under investigation include: BI 836858 (DRUG), Best Supportive Care (PROCEDURE).
Who is sponsoring clinical trial NCT02240706?
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 NCT02240706's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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