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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00666926 |
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: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
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 |
Estimated Enrollment: | 46 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: PF00562271
125 mg BID with food, tablet
|
2: Experimental |
Drug: PF00562271
125 mg BID with food, tablet
|
3: Experimental |
Drug: PF00562271
125 mg BID with food, tablet
|
4: Experimental |
Drug: PF00562271
125 mg BID with food, tablet
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer Oncology Clinical Trial Information Service | 1-877-369-9753 | PfizerCancerTrials@emergingmed.com |
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
United States, Colorado | |
Pfizer Investigational Site | Recruiting |
Aurora, Colorado, United States, 80010 | |
Pfizer Investigational Site | Recruiting |
Aurora, Colorado, United States, 80045 | |
United States, Tennessee | |
Pfizer Investigational Site | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Australia, Victoria | |
Pfizer Investigational Site | Recruiting |
East Melbourne, Victoria, Australia, 3002 | |
Canada, Ontario | |
Pfizer Investigational Site | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director/Clinical Trials Disclosure Group ) |
Study ID Numbers: | A8031001 |
Study First Received: | March 26, 2008 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00666926 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pancreatic Neoplasm, Head and Neck neoplasm, Prostatic neoplasms; Focal Adhesion Kinase, Phase 1, Pharmacodynamics, FDG-PET |
Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Pancreatic Neoplasms Endocrine System Diseases Adhesions Urogenital Neoplasms Genital Diseases, Male |
Digestive System Diseases Head and Neck Neoplasms Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Prostatic Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Prostatic Diseases Genital Neoplasms, Male Pancreatic Neoplasms Endocrine System Diseases Urogenital Neoplasms Genital Diseases, Male |
Neoplasms Neoplasms by Site Digestive System Diseases Head and Neck Neoplasms Pancreatic Diseases Prostatic Neoplasms Endocrine Gland Neoplasms |