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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00666926

Purpose

Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-00562271 in patients with positive 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 FDG-PET and tumor imaging, medical history, physical examination 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.

Condition	Intervention	Phase
Head and Neck Neoplasm Prostatic Neoplasm Pancreatic Neoplasm	Drug: PF00562271	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-00562271 In Patients With Advanced Non-Hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Pancreatic Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

In patients with pancreatic, head and neck, or prostatic neoplasms, outcomes will include safety, tolerability, antitumor activity, and changes in biomarkers [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Safety, tolerability, antitumor activity [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics, pharmacodynamics, and antitumor activity by RECIST criteria [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment:	106
Study Start Date:	December 2005
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: PF00562271 125 mg BID with food, tablet
Experimental: 2	Drug: PF00562271 125 mg BID with food, tablet
Experimental: 3	Drug: PF00562271 125 mg BID with food, tablet
Experimental: 4	Drug: PF00562271 125 mg BID with food, tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666926

Locations

United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80010
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia, 3002
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director/Clinical Trials Disclosure Group, Pfizer
ClinicalTrials.gov Identifier:	NCT00666926 History of Changes
Other Study ID Numbers:	A8031001
Study First Received:	March 26, 2008
Last Updated:	July 10, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pancreatic Neoplasm, Head and Neck neoplasm, Prostatic neoplasms; Focal Adhesion Kinase, Phase 1, Pharmacodynamics, FDG-PET

Additional relevant MeSH terms:

Neoplasms
Head and Neck Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Endocrine Gland Neoplasms

Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012