First-in-human Phase 1 open label study of the BET inhibitor ODM-207 in patients with selected solid tumours.

ABSTRACT:

Background

Bromodomain and extra-terminal domain (BET) proteins are reported to be epigenetic anti-cancer drug targets. This first-in-human study evaluated the safety, pharmacokinetics and preliminary anti-tumour activity of the BET inhibitor ODM-207 in patients with selected solid tumours.

Methods

This was an open-label Phase 1 study comprised of a dose escalation part, and evaluation of the effect of food on pharmacokinetics. ODM-207 was administered orally once daily. The dose escalation part was initiated with a dose titration in the initial cohort, followed by a 3 + 3 design.

Results

Thirty-five patients were treated with ODM-207, of whom 12 (34%) had castrate-resistant prostate cancer. One dose-limiting toxicity of intolerable fatigue was observed. The highest s

SUBMITTER: Ameratunga M 

PROVIDER: S-EPMC7722752 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature