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NCT03166631 · ClinicalTrials.gov registry record · Phase 1
A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
NCT03166631: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.
NCT03166631 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03166631, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
Study Summary
The main objective of the dose-escalation parts of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for further development of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and to evaluate its safety and tolerability by monitoring the occurrence and severity of adverse events (AEs). Secondary objectives are the determination of the pharmacokinetic (PK) profile of BI 891065 monotherapy as well as of BI 891065 in combination with BI 754091, and the preliminary assessment of anti-tumour activity.
Primary Outcome
Maximum tolerated dose (MTD) defined as the highest dose with less than 25% risk of the true Dose-limiting toxicity (DLT) rate being above 33% during the MTD evaluation period.
Interventions
- DRUG BI 754091
- DRUG BI 891065
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-09-08 |
| Est. Completion | 2020-10-28 |
| Phase | Phase 1 |
Why NCT03166631 stopped before completion
NCT03166631 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which BI 754091 is the first listed.
NCT03166631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03166631 about?
NCT03166631 is a clinical study titled "A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread". The main objective of the dose-escalation parts of the trial is to determine the maximum tolerated dose (MTD), based on the frequency of patients experiencing dose-limiting toxicities (DLTs), and/or the recommended dose for further development of BI 891065 monotherapy as well as of BI 891065 in comb...
What is the current status of trial NCT03166631?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2017-09-08. Estimated completion is 2020-10-28.
What interventions are being tested in trial NCT03166631?
The interventions under investigation include: BI 754091 (DRUG), BI 891065 (DRUG).
Who is sponsoring clinical trial NCT03166631?
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 NCT03166631's enrollment target sits among peer trials
62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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