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eltrombopag olamine

Phase 1

Myelodysplastic Syndrome | Small molecule | Hematology |GSK plc|Last Updated: Nov 13, 2017

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment98
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00903422Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)PHASE1 COMPLETED 98 — — May 14, 2009Dec 5, 2013Nov 13, 201765 United States, Brazil +9
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Study Endpoints
Primary Endpoints
Safety and tolerability parameters including non-hematological laboratory Grade 3/Grade 4 toxicities, change in bone marrow blast counts from baseline and adverse events reporting.
Approximately 46 months
Secondary Endpoints
Proportion of subjects with a baseline platelet count <20 Gi/L and an increase to >20 Gi/L and by at least 2x baseline; or a baseline platelet count between >=20-<30 Gi/L and an absolute platelet count increase to >=50 Gi/L at any time during treatment.
Approx. 46 months
Frequency and number of units of platelet transfusions during the treatment and follow-up periods for eltrombopag- and placebo-treated subjects.
approx 46 months
The incidence and severity of bleeding events, measured using the World Health Organization (WHO) Bleeding Scale, during the treatment and 4 week follow-up periods for eltrombopag- and placebo-treated subjects.
approx. 46 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EltrombopagACTIVE_COMPARATOREltrombopag
PlaceboPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
eltrombopag olamineDRUGthrombopoietin receptor agonist
PlaceboOTHERPlacebo tablets with no active pharmaceutical ingredient
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites65

Inclusion Criteria: * Adult subjects (18 years of age or older) with advanced MDS, sAML/MDS, or de novo AML with \>=10% and \<=50% blasts in bone marrow. Peripheral blood blast change over time should not be suggestive of highly proliferative disease (as judged by the investigator). * Subjects must...

Countries:United StatesBrazilDenmarkFranceGermanyHong KongItalyPuerto RicoSouth KoreaTaiwanUnited Kingdom
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY10PHASE3Luspatercept, Epoetin Alfa, Epoetin alfa, Azacitidine, BMS-986497
AbbVie, Inc.ABBV3PHASE3Venetoclax, Azacitidine, venetoclax + azacitidine +/- donor lymphocyte infusion
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK4PHASE3Elritercept, Epoetin Alfa, TAK-226
argenx SE Sponsored ADRARGX1PHASE3Empasiprubart, IVIG
Incyte CorporationINCY4PHASE2Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C, Conditioning Regimen D, Conditioning Regimen E
Novartis AG Sponsored ADRNVS2PHASE2decitabine, spartalizumab, sabatolimab, azacitidine, venetoclax
Geron CorporationGERN3PHASE2Imetelstat, Cytarabine, Fludarabine, Hydrocortisone, Leucovorin Calcium
GSK plc Sponsored ADRGSK1PHASE2Momelotinib
Agios Pharmaceuticals, Inc.AGIO1PHASE2Tebapivat
ICON PlcICLR1PHASE2SP-420
Ascentage Pharma Group International Unsponsored ADRAAPG2PHASE3Lisaftoclax, Azacitidine, APG-115, Cytarabine
Tango Therapeutics, Inc.TNGX2PHASE3Ivosidenib, Azacitidine, AG-120
Johnson & JohnsonJNJ3PHASE1JNJ-89853413, JNJ-75348780, JNJ-67856633, JNJ-54179060, JNJ-64264681
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
TScan Therapeutics, Inc.TCRX2PHASE1Undisclosed
Pfizer Inc.PFE1PHASE1SEA-CD70, azacitidine, Venetoclax
Precigen IncPGEN1PHASE1PRGN-3006 T Cells
AstraZeneca PLCAZN1PHASE1AZD3632, Posaconazole
Foghorn Therapeutics, Inc.FHTX1PHASE1FHD-286, Low Dose Cytarabine, Decitabine
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