Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes

Summary

Phase I: To investigate maximum tolerated dose (MTD), safety and tolerability, pharmacokinetics, exploratory biomarker and efficacy of BI 836858 monotherapy in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS) with symptomatic anemia. Phase II: To investigate safety and efficacy of BI 836858 plus Best Supportive Care compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia.

Timeline

Start

2015-01-22

Primary completion

2019-11-18

Completion

2019-11-18

Drugs

Indications