Trials / Completed
CompletedNCT04147247
A Trial to Find the Safe Dose for BI 905681 in Patients With Incurable Tumours or Tumours That Have Spread
An Open-label, Phase I Trial to Determine the Maximum-tolerated Dose and Investigate Safety, Pharmacokinetics and Efficacy of BI 905681 Administered Intravenously in Patients With Advanced Solid Tumours
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Study was opened to recruitment until 29-Oct-2021, however from 15-Apr-2021 no patient was recruited.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BI 905681 | Infusion |
Timeline
- Start date
- 2019-12-23
- Primary completion
- 2021-05-06
- Completion
- 2021-05-27
- First posted
- 2019-11-01
- Last updated
- 2023-11-29
- Results posted
- 2023-11-29
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04147247. Inclusion in this directory is not an endorsement.