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NCT03449381 · ClinicalTrials.gov registry record · Phase 1
This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)
A Phase 1 study of Neoplasms, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 1
- Development phase
- 266
- Enrollment target
- 20
- Study locations
NCT03449381: Completed Phase 1 study of Neoplasms, sponsored by Boehringer Ingelheim.
NCT03449381 is a Phase 1 study of Neoplasms that has completed, run by Boehringer Ingelheim. The registered enrollment target is 266 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03449381, a Phase 1 study of Neoplasms, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 266 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumors shrink. In this study, brigimadlin is given to humans for the first time. Brigimadlin is a so-called MDM2 inhibitor that is being developed to treat cancer. Brigimadlin is taken as a tablet. Participants either take a dose of brigimadlin on one day every 3 weeks or on two days every 4 weeks. The participants are in the study for as long as they benefit from and can tolerate treatment. The doctors regularly check the participants' general health during the study.
Conditions Studied
Interventions
- DRUG BI 907828
Study Locations (20)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- UZ Leuven - Leuven
- Rigshospitalet, København - København Ø
- Helios Klinikum Berlin-Buch - Berlin
- Universitätsklinikum Köln (AöR) - Cologne
- Universitätsmedizin Göttingen, Georg-August-Universität - Göttingen
- Universitätsklinikum Tübingen - Tübingen
- Sourasky Medical Center - Tel Aviv
- National Cancer Center Hospital - Tokyo, Chuo-ku
- MED POLONIA SP Z O O, Clinical Trials Department,Poznan - Poznan
California
- Sarcoma Oncology Center - Santa Monica
Connecticut
- Yale University School of Medicine - New Haven
Florida
- Florida Cancer Specialists-Sarasota-61670 - Sarasota
Kentucky
- Norton Cancer Institute, Downtown - Louisville
Michigan
- START Midwest - Grand Rapids
New York
- Memorial Sloan-Kettering Cancer Center - New York
Tennessee
- SCRI Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2025-11-13 |
| Phase | Phase 1 |
What the finished NCT03449381 record still lists
NCT03449381 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which BI 907828 is the first listed.
NCT03449381 names 20 study sites across 11 states, led by Other, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03449381 about?
NCT03449381 is a clinical study titled "This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)". This study is open to adults with different types of advanced cancer (solid tumors). The purpose of this study is to find out the most suitable dose of BI 907828 (brigimadlin) the participants can tolerate. The most suitable dose is used in the second part to find out whether brigimadlin makes tumor...
What is the current status of trial NCT03449381?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 266 participants. The study started on 2018-06-20. Estimated completion is 2025-11-13.
What conditions does trial NCT03449381 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT03449381?
The interventions under investigation include: BI 907828 (DRUG).
Who is sponsoring clinical trial NCT03449381?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03449381 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03449381's enrollment target sits among peer trials
266 36th of 158 higher than 123 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms 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.
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