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ZARNESTRA, tipifarnib, R115777

Phase 2

Myelodysplastic Syndrome | Small molecule | Hematology |Johnson & Johnson|Last Updated: Apr 27, 2010

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 Enrollment82
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00050154Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome (MDS)PHASE2 COMPLETED 82Jul 1, 2002May 1, 2006Apr 27, 2010 -
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Study Endpoints
Primary Endpoints
The purpose of this research study is to determine if tipifarnib leads to a complete response for in patients with high-risk Myelodysplastic Syndrome (MDS).
Secondary Endpoints
Efficacy will be assessed by evaluation of bone marrow and hematologic laboratory tests. Safety will be assessed by evaluation of adverse events and clinical laboratory tests.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ZARNESTRA, tipifarnib, R115777DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Pathological evidence of MDS * Not more than 1 prior cytotoxic treatment for MDS * Able to take oral study drug * Able to understand and provide signed informed consent Exclusion Criteria: * Refractory anemia (RA) or RA with excess of blasts (RAEB) or patients with RAEB with...

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Competitive Landscape -Myelodysplastic Syndromes 76 trials
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