NCT00666926

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

A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-00562271 In Patients With Advanced Non-Hematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Verastem, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Neoplasm
• Prostatic Neoplasm
• Pancreatic Neoplasm

Interventions

Type	Name	Description
DRUG	PF00562271	125 mg twice daily \[BID\] with food, tablet
DRUG	PF00562271	125 mg BID with food, tablet
DRUG	PF00562271	125 mg BID with food, tablet
DRUG	PF00562271	125 mg BID with food, tablet

Timeline

• Start date: 2005-12-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-04-25
• Last updated: 2013-03-21
• Results posted: 2012-06-14

Locations

4 sites across 3 countries: United States, Australia, Canada