drugset / Trial / NCT00666926

Study Of PF-00562271, Including Patients With Pancreatic, Head And Neck, Prostatic Neoplasms

NCT00666926 ↗

Phase 1 Completed 99 enrolled Verastem, Inc.
Non-randomizedCrossoverOpen-labelTreatment

Summary

Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive Positron Emission Tomography \[PET\] scans due to advanced non-hematologic malignancies, including pancreatic, head and neck, and prostatic neoplasms, and patients with other malignancies appropriate for serial biopsy. Screening consists of a Fluorodeoxyglucose Positron Emission Tomography \[FDG-PET\] and tumor imaging, medical history, physical examination, Eastern Cooperative Oncology Group \[ECOG\] performance status, blood draws, a pregnancy test for female patients of childbearing potential. Treatment consists of PF00562271 tablets 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 kinase activities.

Timeline

Start
2005-12
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PF00562271 Small molecule 125 mg —