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Recently added Catalysts

MEK162, MEK inhibitor;

Phase 1

Epithelial Ovarian Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 14, 2020

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01649336A Study of MEK162 and Paclitaxel in Patients With Epithelial Ovarian, Fallopian Tube or Peritoneal CancerPHASE1 COMPLETED 36 — — Jul 1, 2012Mar 1, 2016Sep 14, 20204 United States
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Study Endpoints
Primary Endpoints
Establish the recommended Phase 2 dose of study drug administered on continuous and intermittent schedules in combination with paclitaxel.
One year
Secondary Endpoints
Characterize the safety profile of the study drug in combination with paclitaxel in terms of adverse events and clinical laboratory tests.
One year
Assess the efficacy of the study drug in combination with paclitaxel in terms of tumor response, duration of response and progression-free survival.
One year
Assess the potential plasma pharmacokinetic (PK) interactions between study drug, metabolites and paclitaxel in terms of plasma concentrations and noncompartmental PK parameters.
One year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEK162 + paclitaxelEXPERIMENTAL -
Interventions
NameTypeDescription
MEK162, MEK inhibitor; oralDRUGmultiple dose, escalating
Paclitaxel, mitotic inhibitor; intravenousDRUGmultiple dose, single schedule
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria: * Histologically confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer (measurable or evaluable, nonmeasurable disease) that is platinum-resistant or refractory. In the judgment of the Investigator, a patient who is platinum-sensitive but wou...

Countries:United States
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