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Elsamitrucin

Phase 2

Mantle Cell Lymphoma | Small molecule | Oncology |Assertio Holdings, Inc.|Last Updated: Jan 15, 2008

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
UNCONTROLLED
Total Trials1
Total Enrollment114
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00090090Elsamitrucin (SPI 28090) for Relapsed or Refractory Non-Hodgkin's LymphomaPHASE2 COMPLETED 114Apr 1, 2004Oct 1, 2006Jan 15, 20087 United States
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ElsamitrucinDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Relapsed or Refractory mantle cell lymphoma and/or CLL/SLL except Burkitt's, Burkitt's like or HIV-associated lymphoma * at least one prior cytotoxic chemotherapy regimens * measurable disease * adequate bone marrow, liver and kidney function * ECOG PS 0-2 Exclusion Criteria:...

Countries:United States
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