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PF-04554878

Phase 1

Cancer | Small molecule | Oncology |Verastem, Inc.|Last Updated: Jan 25, 2017

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
UNCONTROLLED
Total Trials1
Total Enrollment46
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00787033A Study Of PF-04554878 In Patients With Advanced Non-Hematologic MalignanciesPHASE1 COMPLETED 46Dec 1, 2008Feb 1, 2012Jan 25, 20175 United States, Canada
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Study Endpoints
Primary Endpoints
Recommended Phase 2 Dose
18 months
Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
18 months
Secondary Endpoints
Tumor metabolic response
18 months
PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters
18 months
FAK-related biomarkers in tumor biopsies and blood
18 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDose escalation study with Expansion Cohorts at RP2D and Schedule
Interventions
NameTypeDescription
PF-04554878DRUGOral pills at increasing dose twice daily, 21 day cycle, continuous treatment schedule until progression of disease, unacceptable toxicity, or patient request. Some patients will undergo serial biopsy and/or FDG-PET imaging
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Patients with advanced non-hematologic malignancies. * Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. Exclusion Criteria: * Clinically significant gastrointestinal abnormalities, requ...

Countries:United StatesCanada
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