Conditions: Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm
Keywords: Pancreatic Neoplasm Head and Neck neoplasm Prostatic neoplasms; Focal Adhesion Kinase Phase 1 Pharmacodynamics FDG-PET
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 99
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: PF00562271 intervention 2: PF00562271 intervention 3: PF00562271 intervention 4: PF00562271
Intervention descriptions: intervention 1: 125 mg twice daily \[BID\] with food, tablet intervention 2: 125 mg BID with food, tablet intervention 3: 125 mg BID with food, tablet intervention 4: 125 mg BID with food, tablet

Protocol document: