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/PN-196,444

Phase 3

Neoplasms | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Nov 9, 2006

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
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment180
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00037791Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of ThrombocytopeniaPHASE3 COMPLETED 180Dec 1, 1999Sep 1, 2002Nov 9, 20069 United States, Argentina +1
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Study Endpoints
Primary Endpoints
To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
Secondary Endpoints
Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
(PN-152,243)/PN-196,444DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Patients must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support Exclusion Criteria: * Patients must not have active bleeding (exclusions do apply) or history of platelet disorder

Countries:United StatesArgentinaMexico
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