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MDX-060

Phase 2

Hodgkin's Disease | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Oct 12, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00284804A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's DiseasePHASE2 COMPLETED 74Nov 1, 2005Oct 1, 2009Oct 12, 201517 United States
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Study Endpoints
Primary Endpoints
Overall response rate
Day 50/57
Secondary Endpoints
Progression-free survival
Day 50/57
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MDX-060 plus standard of careEXPERIMENTALMDX-060 in combination with gemcitabine
Standard of careACTIVE_COMPARATORGemcitabine
Interventions
NameTypeDescription
MDX-060DRUGanti-CD30 monoclonal antibody, i.v. weekly x 3 10 mg/kg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD) * Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained...

Countries:United States
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