Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. Screening consists of medical history, physical examination ECOG performance status, blood draws, a pregnancy test for female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of PF-04554878 pills continued until progression of disease, unacceptable toxicity, or patient request. Evaluations for bioactivity are measured by serial FDG-PET and blood tests for biomarkers related to FAK and Pyk2 activities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Oral 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
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Nashville, Tennessee, United States
Pfizer Investigational Site
Toronto, Ontario, Canada
Recommended Phase 2 Dose
Time frame: 18 months
Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
Time frame: 18 months
Tumor metabolic response
Time frame: 18 months
PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters
Time frame: 18 months
FAK-related biomarkers in tumor biopsies and blood
Time frame: 18 months
Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples
Time frame: 18 months
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