NCT02516553

BI 894999 First in Human Dose Finding Study in Advanced Malignancies

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasms
• NUT Carcinoma

Interventions

Type	Name	Description
DRUG	BI 894999	film-coated tablets

Timeline

• Start date: 2015-07-08
• Primary completion: 2021-11-23
• Completion: 2021-11-23
• First posted: 2015-08-06
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

16 sites across 6 countries: United States, Belgium, France, Germany, South Korea, Spain