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NCT02516553 · ClinicalTrials.gov registry record · Phase 1
BI 894999 First in Human Dose Finding Study in Advanced Malignancies
A Phase 1 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 174
- Enrollment target
NCT02516553: Completed Phase 1 study, sponsored by Boehringer Ingelheim.
NCT02516553 is a Phase 1 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 174 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (190% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02516553, a Phase 1 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 174 participants
- Enrollment target
Study Summary
This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carcinoma can also participate. No standard treatment exists for this rare and aggressive form of cancer. The purpose of this study is to find out the highest dose of BI 894999 that people can tolerate. BI 894999 is tested for the first time in humans. Participants take tablets once daily. The study also tests whether participants can tolerate BI 894999 better when taken continuously or with breaks in between. Participants can stay in the study as long as they benefit from the treatment and can tolerate it. The doctors also regularly check the general health of the participants.
Primary Outcome
Number of patients with Dose Limiting Toxicities (DLTs) observed in the first treatment cycle of Phase Ia is reported. The following drug related adverse events (AEs) qualified as DLT: * any Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3 non haematological toxicity considered related to trial medication with the following exceptions: * inadequately treated nausea, vomiting or diarrhoea. For fatigue, if present at baseline, there had to be an increase of ≥2 grades * electr
Interventions
- DRUG BI 894999
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2015-07-08 |
| Est. Completion | 2021-11-23 |
| Phase | Phase 1 |
What the finished NCT02516553 record still lists
NCT02516553 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (190% higher).
The record links to 0 conditions, and to 1 intervention - of which BI 894999 is the first listed.
NCT02516553 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02516553 about?
NCT02516553 is a clinical study titled "BI 894999 First in Human Dose Finding Study in Advanced Malignancies". This study is open to adults with different types of advanced cancer (solid tumours). The study is also open to patients with diffuse large B-cell lymphoma in whom previous treatment was not successful. In some countries, adolescents who are at least 15 years old and who are diagnosed with NUT carci...
What is the current status of trial NCT02516553?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 174 participants. The study started on 2015-07-08. Estimated completion is 2021-11-23.
What interventions are being tested in trial NCT02516553?
The interventions under investigation include: BI 894999 (DRUG).
Who is sponsoring clinical trial NCT02516553?
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 NCT02516553's enrollment target sits among peer trials
174 322nd of 2000 higher than 1,677 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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