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tipifarnib

Phase 2

Leukemia, Nonlymphocytic, Acute | Small molecule | Oncology |Johnson & Johnson|Last Updated: Feb 1, 2011

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 Enrollment252
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00354146A Phase 2 Study of Farnesyl Transferase Inhibitor (R115777, Tipifarnib) in Patients With Refractory or Relapsed Acute Myeloid Leukemia.PHASE2 COMPLETED 252 — — Apr 1, 2001Jul 1, 2003Feb 1, 2011 - —
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Study Endpoints
Primary Endpoints
The objective is to determine the rate of complete remission or complete remission with incomplete platelet recovery induced by tipifarnib in patients with refractory or relapsed AML treated until disease progression or unacceptable toxicity occurs.
Secondary Endpoints
These objectives are to determine the objective remission rate, duration of remission, time to disease progression/progression-free survival, overall survival, and the clinical benefit/quality of life (QOL). The safety profile will also be determined.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
tipifarnib (R115777)DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Refractory or relapsed Acute myeloid leukemia (AML) * Eastern Cooperative Oncology Group (ECOG) performance of 0-2 * any value of WBC * able to eat food and medication orally * females must use contraception and not be pregnant Exclusion Criteria: * .Not in another study wit...

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