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Forodesine

Phase 2

Cutaneous T-cell Lymphoma (CTCL), | Small molecule | Oncology |BioCryst Pharmaceuticals, Inc.|Last Updated: Jan 23, 2012

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 Enrollment144
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00501735Forodesine in the Treatment of Cutaneous T-Cell LymphomaPHASE2 COMPLETED 144Jul 1, 2007Dec 1, 2011Jan 23, 201241 United States, Australia +8
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Study Endpoints
Primary Endpoints
The primary objective of this study is to determine the objective response rate to treatment with oral forodesine in subjects with cutaneous manifestations of CTCL subjects, stages IIB, III, and IVA.
Duration of Study
Secondary Endpoints
Safety and tolerability
Duration of Study
Time to and duration of objective response in cutaneous manifestations
Duration of Study
Time to loss of objective response
Duration of Study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
Forodesine 200 mgDRUG2 x 100mg tablets once daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites41

Inclusion Criteria: * Males or non-pregnant females aged ≥18 years; * Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sezary syndrome, documentation of diagnosis by histologic examination should be available; * Subjects with CTCL stages IB, IIA, IIB, III, or IVA at th...

Countries:United StatesAustraliaAustriaFinlandFranceGermanyItalySpainSwitzerlandUnited Kingdom
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Competitive Landscape -Cutaneous T-Cell Lymphoma 4 trials