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LY2784544

Phase 1

Myeloproliferative Disorders | Small molecule | Hematology |Eli Lilly and Company|Last Updated: Apr 17, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01134120A Study in Myeloproliferative DisordersPHASE1 COMPLETED 80 — — Apr 1, 2010Feb 22, 2018Apr 17, 20182 United States
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Study Endpoints
Primary Endpoints
Determination of a recommended Phase 2 dosing regimen
Time of first dose until last dose
Number of participants with clinical significant effects
Time of first dose until last dose
Secondary Endpoints
Preliminary pharmacokinetics of LY2784544 (Cmax)
Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113
Preliminary pharmacokinetics of LY2784544 (AUC)
Part A1: Day 1,2,15, and 29; Part A2: Day 7, 14, 21, 28, 29, 56, and 57; Part B: Day 1, 29, 57, and 113
Malignant clone burden
Part A1: Baseline (2 times), Weeks 13, 21 and every 6 months while patient is on study; Parts A2 and B: Baseline (2 times), Weeks 5, 8, 17, 25 and every 6 months while patient is on study
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY2784544EXPERIMENTAL -
Interventions
NameTypeDescription
LY2784544DRUGLY2784544 will be supplied as a capsule. The study drug will be taken by mouth daily while the patient is on study. In this study, different patients will be treated at different doses of LY2784544 until reaching the highest dose that patients can tolerate.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Have a diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) as defined by the World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms and meet the following additional sub-type specific criteria: A. PV: has fa...

Countries:United States
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