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CC-5013

Phase 2

Myelodysplastic Syndromes | Small molecule | Hematology |Bristol-Myers Squibb Company|Last Updated: Apr 4, 2013

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment215
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00064974Efficacy and Safety Study of CC-5013 Monotherapy in Subjects With Myelodysplastic SyndromesPHASE2 COMPLETED 215Jun 1, 2003Feb 1, 2007Apr 4, 2013119 United States, Australia +13
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Study Endpoints
Primary Endpoints
RBC Transfusion Independence
Secondary Endpoints
≥ 50% decrease in RBC transfusion requirement
Platelet Response
Neutrophil Response
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CC-5013EXPERIMENTALCC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
Interventions
NameTypeDescription
CC-5013DRUGCC-5013 10 mg (two 5 mg capsules) daily on days 1-28 every 28 days (28 day cycles)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites119

Inclusion Criteria: * Must understand and voluntarily sign an informed consent form. * Age ≥ 18 years at the time of signing the informed consent form. * Must be able to adhere to the study visit schedule and other protocol requirements. * Diagnosis of low - or intermediate-1-risk IPSS (Appendix II...

Countries:United StatesAustraliaBelgiumCzechiaDenmarkFranceGermanyGreeceItalyNetherlandsRussiaSpainSwedenSwitzerlandUnited Kingdom
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
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