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Tipifarnib;Zarnestra; R115777

Phase 3

Acute Myeloid Leukemia | Small molecule | Oncology |Johnson & Johnson|Last Updated: Sep 14, 2016

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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment457
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00093990Tipifarnib Versus Best Supportive Care in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)PHASE3 COMPLETED 457 — — Jan 1, 2004Oct 1, 2007Sep 14, 2016 - —
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Study Endpoints
Primary Endpoints
Overall survival
Secondary Endpoints
Compare patients treated with tipifarnib and patients treated with best supportive care: progression-free survival; complete remission rate; rate of morphologic leukemia-free state; one-year survival estimate and health resources utilization.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Tipifarnib;Zarnestra; R115777DRUG -
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Eligibility Criteria
Age Range70 Years — 99 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Newly diagnosed or re-lapsing AML * Patient not medically fit for combination induction chemotherapy * Pathologic confirmation of AML (= or \> 20% bone marrow leukemic blasts) * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Exclusion Criteria: * Pr...

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