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BEZ235 + MEK162

Phase 1

Unspecified Adult Solid Tumor, Protocol Specific | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 9, 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 Enrollment29
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01337765Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor PatientsPHASE1 COMPLETED 29 — — Jul 8, 2011Mar 22, 2013Oct 9, 20206 United States, Australia +3
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities
during Cycle 1 of treatment with BEZ235 and MEK162

A complete treatment cycle is defined as 28 days of daily continuois treatment with study drug combination

Secondary Endpoints
Number of participants with adverse events and serious adverse events
from Cycle 1 Day 1 until treatment discontinuation
Overall response rate, duration of response, time to response and progression free survival
every 8 weeks of treatment
Time versus plasma concentration profiles of BEZ235 and MEK162
during the first cycle of treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BEZ235 + MEK162EXPERIMENTAL -
Interventions
NameTypeDescription
BEZ235 + MEK162DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * histologically/cytologically confirmed, advanced non resectable solid tumors * Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0 Exclusion Criteria: * Patients with primary CNS tumor or CNS tumor involvement * Diabetes mellitus - Unacceptable oc...

Countries:United StatesAustraliaCanadaFranceSpain
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