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NCT04147247 · ClinicalTrials.gov registry record · Phase 1
A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT04147247 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 21 participants.
The verdict
NCT04147247, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905681. The MTD will be defined based on the frequency of patients experiencing dose-limiting toxicities (DLTs) during the MTD/DLT evaluation period, which is defined as the first cycle of treatment. Separate MTDs will be determined for Schedule A and Schedule B. The secondary objective of the trial is to determine the pharmacokinetic (PK) profile of BI 905681.
Interventions
- DRUG BI 905681
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-12-23 |
| Est. Completion | 2021-05-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04147247
The ClinicalTrials.gov registry entry for NCT04147247 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 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 1 intervention - of which BI 905681 is the first listed.
NCT04147247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04147247 about?
NCT04147247 is a clinical study titled "A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread". The primary objective of this trial is to determine the maximum tolerated dose (MTD)/optimal biological dose (OBD) of BI 905681 given as an intravenous infusion and to determine the recommended dose and dosing schedule for further trials in the development of BI 905681. The MTD will be defined based...
What is the current status of trial NCT04147247?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-12-23. Estimated completion is 2021-05-27.
What interventions are being tested in trial NCT04147247?
The interventions under investigation include: BI 905681 (DRUG).
Who is sponsoring clinical trial NCT04147247?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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