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CC-1088

Phase 2

Myelodysplastic Syndrome | Small molecule | Hematology |Bristol-Myers Squibb Company|Last Updated: Apr 25, 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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00045786Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic SyndromesPHASE2 COMPLETED 18Oct 1, 2001Nov 1, 2003Apr 25, 20171 United States
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
400 mg CC-1088EXPERIMENTAL -
800 mg CC-1088EXPERIMENTAL -
1200 mg CC-1088EXPERIMENTAL -
1500 mg CC-1088EXPERIMENTAL -
Interventions
NameTypeDescription
CC-1088DRUG400 mg/day (200 mg orally twice a day) 800 mg/day (400 mg orally twice a day) 1200 mg/day (600 mg orally twice a day) 1500 mg/day (500 mg orally three times daily)
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Eligible patients must have a diagnosis of MDS of at least 12 weeks that is not therapy related. * Age ≥ 18 at the time of signing informed consent * Patient must be able to adhere to the study visit schedule and other protocol requirements. * Patient must understand and volun...

Countries:United States
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Competitive Landscape -Myelodysplastic Syndromes 76 trials
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