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MGCD0103

Phase 2

Lymphocytic Leukemia, Chronic | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 1, 2015

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 Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00431873A Phase II Study of MGCD0103 (MG-0103) in Patients With Refractory Chronic Lymphocytic LeukemiaPHASE2 COMPLETED 21Jan 1, 2007Nov 1, 2008Jul 1, 201513 United States, Canada
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Study Endpoints
Primary Endpoints
Response rate
1 year (anticipated)
Secondary Endpoints
Duration of objective response
1 year (anticipated)
Safety profile
1 year (anticipated)
Pharmacodynamics (biomarkers)
1 year (anticipated)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMGCD0103 administered orally three times per week.
Interventions
NameTypeDescription
MGCD0103DRUGMGCD0103 Administered orally three times per week.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Pathologic confirmation of CLL. * Prior Treatment. There will be no limit to prior therapy. Therapy with fludarabine and Rituxan must have failed (disease progression, intolerance, or not a candidate). * Age 18 years or greater. * ECOG performance status of 0 or 1. * Laborator...

Countries:United StatesCanada
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