Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
Status:
Terminated
Trial end date:
2019-11-18
Target enrollment:
Participant gender:
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.