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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 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03166631
The ClinicalTrials.gov registry entry for NCT03166631 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BI 754091 is the first listed.
NCT03166631 reports 0 study locations.
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.
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