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NCT06528093 · ClinicalTrials.gov registry record · Phase 1
A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT06528093: Clinical Trial Phase 1 study, sponsored by Boehringer Ingelheim.
NCT06528093 is a Phase 1 study that was terminated before completion, run by Boehringer Ingelheim. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06528093, a Phase 1 study, was terminated before completion, sponsored by Boehringer Ingelheim.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemotherapy. Another purpose is to check whether BI 765883 helps people with advanced pancreatic cancer. In this study, BI 765883 is given to humans for the first time. Participants receive either BI 765883 alone or BI 765883 in combination with chemotherapy. Participants can stay in the study as long as they benefit from treatment and can tolerate it. At study visits, doctors collect information on any health problems of the participants and check the severity of participants' cancer.
Primary Outcome
All Dose-Limiting Toxicities (DLTs) were agreed upon by the Dose-Escalation Committee (DEC) after review of the data from each cohort. Only Dose-Limiting Toxicities (DLTs) occurring in the first 2 cycles were considered necessary for dose-escalation decisions made by the Dose-Escalation Committee (DEC). Dose-Limiting Toxicities (DLTs) observed during the Maximum Tolerated Dose (MTD) evaluation period were considered for Maximum Tolerated Dose (MTD) determination. The MTD evaluation period was d
Interventions
- DRUG nab-paclitaxel
- DRUG gemcitabine
- DRUG BI 765883
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-10-16 |
| Est. Completion | 2025-06-19 |
| Phase | Phase 1 |
Why NCT06528093 stopped before completion
NCT06528093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which nab-paclitaxel is the first listed.
NCT06528093 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06528093 about?
NCT06528093 is a clinical study titled "A Study to Find a Suitable Dose of BI 765883 and to Test Whether it Helps People With Advanced Pancreatic Cancer When Taken Alone or Together With Chemotherapy". This study is open to adults with advanced pancreatic cancer for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find the highest dose of BI 765883 that people with advanced pancreatic cancer can tolerate when taken alone or together with chemother...
What is the current status of trial NCT06528093?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2024-10-16. Estimated completion is 2025-06-19.
What interventions are being tested in trial NCT06528093?
The interventions under investigation include: nab-paclitaxel (DRUG), gemcitabine (DRUG), BI 765883 (DRUG).
Who is sponsoring clinical trial NCT06528093?
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 NCT06528093's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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