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A Phase I/II, Multicenter, Open-label, Dose Escalation and Randomized Trial of BI 836858 in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes
The purpose of this research study is to: Identify the maximum tolerated dose; that is, the highest dose of the study drug BI 836858 that does not cause unacceptable side effects, to help determine the dose for the second phase of this study; Obtain information on the safety and effectiveness in participants given BI 836858 alone; Measure and evaluate the behavior of BI 836858 in the blood: pharmacokinetics or PK testing (what the body does to the drug) and pharmacodynamics (what the drug does to the body).
Phase I: To investigate the 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(BSC) compared to Best Supportive Care alone in low or intermediate-1 risk MDS patients with symptomatic anemia without a deletion 5q cytogenetic abnormality.