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MEK162 + RAF265

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 30, 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 Enrollment69
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01352273MEK162 and RAF265 in Adult Patients With Advanced Solid Tumors Harboring RAS or BRAFV600E MutationsPHASE1 COMPLETED 69Jun 1, 2011Sep 1, 2013Sep 30, 20208 United States, Canada +3
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities
during the first 28 days of treatment with RAF265 and MEK162
Secondary Endpoints
Number of participants with adverse events and serious adverse events
18 months
assess preliminary anti-tumor activity of the combination
every 8 weeks of treatment
Tumor skin and blood samples will be collected before and during treatment with RAF265 and MEK162 to assess the combination's effects on the RAF/MEK/MAPK pathway with the clinical outcomes
18 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MEK162 + RAF265EXPERIMENTAL -
Interventions
NameTypeDescription
MEK162 + RAF265DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: Patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists. * The patients' tumors must contain documented activating somatic BRAFV600E\* , NRAS or KRAS mutations (except for pancreatic...

Countries:United StatesCanadaNorwaySpainSwitzerland
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