Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03449381
The ClinicalTrials.gov registry entry for NCT03449381 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (84% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.