A Study of Galunisertib in Participants With Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of the study drug known as galunisertib in participants with myelodysplastic syndromes (MDS). Participants with different degrees of disease (very low, low, and intermediate risk) will be studied. The study treatment is expected to last about 6 months for each participant.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

Inclusion Criteria:

• Confirmed diagnosis of MDS based on the World Health Organization (WHO) criteria

• Participants with 5q deletions are allowed only if they have failed or are intolerant of lenalidomide treatment

• Participants must have a Revised International Prognostic Scoring System (IPSS-R) category of very low-, low-, or intermediate-risk disease

• In the 8 weeks prior to registration, participants in phase 2 should have anemia with Hb ≤10.0 g/dL (based on the average of 2 baseline measurements and untransfused for at least 1 week) with or without red blood cell (RBC) transfusion dependence confirmed for a minimum of 8 weeks before enrollment

• For phase 3, participants should have anemia with RBC transfusion dependence confirmed within 8 weeks before enrollment

• Performance status ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

• No history of moderate or severe cardiac disease

• No prior history of acute myeloid leukemia (AML)