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COMPLETED Phase 1

This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)

NCT03449381 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 266 participants
Start Date 2018-06-20
Est. Completion 2025-11-13
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03449381 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03449381?

The interventions under investigation include: BI 907828 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03449381?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial