CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 43 enrolled
Drug / intervention
Galunisertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02008318
NCT02008318Phase 3Completed
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Phase 2/3 Study of Monotherapy LY2157299 Monohydrate in Very Low-, Low-, and Intermediate-Risk Patients With Myelodysplastic Syndromes

Eli Lilly and Company·interventional·Posted Dec 11, 2013·Updated Sep 11, 2019

In Brief

A Phase 3 clinical trial evaluating Galunisertib and Placebo for Myelodysplastic Syndromes. Completed, enrolled 43 participants across 14 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesGermany, Italy, Spain
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 11, 2013
Enrollment StartMar 1, 2014
Primary CompletionMar 1, 2016
Study CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.6 years ago

Interventions

Galunisertibdrug

Administered orally

Placebodrug

Administered orally