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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

125 mg twice daily \[BID\] with food, tablet

Intervention Type DRUG

PF00562271

125 mg BID with food, tablet

Intervention Type DRUG

PF00562271

125 mg BID with food, tablet

Intervention Type DRUG

PF00562271

125 mg BID with food, tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pancreatic, head and neck, and prostatic neoplasms, and patients with non-hematologic malignancies who have tumor appropriate for serial biopsy.
* Adequate organ function, including bilirubin less than 1.5 x ULN, and \[Eastern Cooperative Oncology Group\] ECOG performance status of 0-2.

Exclusion Criteria

* Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 3A4 inhibitors, and history of clinically significant cardiac or pulmonary disorders.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No