Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02240706

Phase I/II Trial to Investigate BI 836858 in Myelodysplastic Syndromes
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 
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 riskmyelodysplastic 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 without a deletion 5q cytogenetic abnormality.
Status: 
Recruiting
Study Date: 
Thu, 01/01/2015 to Thu, 11/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Procedure: Best Supportive Care At Discretion of the Investigator (Transfusions) Drug: BI 836858 Monotherapy with BI 836858