A Study of LY2157299 in Participants With Myelodysplastic Syndromes

Status:	Completed
Conditions:	Blood Cancer, Blood Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	5/3/2014
Start Date:	February 2014
End Date:	April 2016
Contact:	There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:	1-317-615-4559

Phase 2/3 Study of Monotherapy LY2157299 Monohydrate in Very Low-, Low-, and Intermediate-Risk Patients With Myelodysplastic Syndromes

The purpose of this study is to investigate the effect of the study drug known as LY2157299
on red blood cells 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.

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)

We found this trial at

sites

Clinical Trial Facility in Bronx New York

Bronx, New York

from

Bronx, NY