CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 174 enrolled
Drug / intervention
BI 894999drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02516553
NCT02516553Phase 1Completed

An Open Label, Phase Ia/Ib Dose Finding Study With BI 894999 Orally Administered Once a Day in Patients With Advanced Malignancies, With Repeated Administration in Patients With Clinical Benefit

Boehringer Ingelheim·interventional·Posted Aug 6, 2015·Updated Apr 15, 2024

In Brief

A Phase 1 clinical trial evaluating BI 894999 for Neoplasms and NUT Carcinoma. Completed, enrolled 174 participants across 16 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, France, Germany, South Korea, Spain, United States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 6, 2015
Enrollment StartJul 8, 2015
Primary CompletionNov 23, 2021
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 10.9 years ago

Interventions

BI 894999drug

film-coated tablets