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BKM120 + MEK162

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 5, 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 Enrollment89
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01363232Safety, Pharmacokinetics and Pharmacodynamics of BKM120 Plus MEK162 in Selected Advanced Solid Tumor PatientsPHASE1 COMPLETED 89 — — Aug 1, 2011Dec 18, 2017Oct 5, 202012 United States, Canada +5
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities
during Cycle 1 of treatment with BKM120 and MEK162
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 BKM120 and MEK162
during the first cycle of treatment on Cycle 1 Day 1 and Cycle 1 Day 15
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BKM120 + MEK162EXPERIMENTAL -
Interventions
NameTypeDescription
BKM120 + MEK162DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites12

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

Countries:United StatesCanadaGermanyNetherlandsSingaporeSpainSwitzerland
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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