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Phase 1 safety, pharmacokinetics, and pharmacodynamics trial of the focal adhesion kinase (FAK) inhibitor PF-04554878 in patients with advanced non-hematologic malignancies, including patients with malignancies appropriate for serial biopsy. Screening consists of medical history, physical examination ECOG performance status, blood draws, a pregnancy test for female patients of childbearing potential, a FDG-PET and tumor imaging. Treatment consists of PF-04554878 pills 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 activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose escalation study with Expansion Cohorts at RP2D and Schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04554878 | Drug | Oral pills at increasing dose twice daily, 21 day cycle, continuous treatment schedule until progression of disease, unacceptable toxicity, or patient request. Some patients will undergo serial biopsy and/or FDG-PET imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Recommended Phase 2 Dose | 18 months | |
| Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT) | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor metabolic response | 18 months | |
| PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters | 18 months | |
| FAK-related biomarkers in tumor biopsies and blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Boston | Massachusetts | 02114 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26334219 | Derived | Jones SF, Siu LL, Bendell JC, Cleary JM, Razak AR, Infante JR, Pandya SS, Bedard PL, Pierce KJ, Houk B, Roberts WG, Shreeve SM, Shapiro GI. A phase I study of VS-6063, a second-generation focal adhesion kinase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2015 Oct;33(5):1100-7. doi: 10.1007/s10637-015-0282-y. Epub 2015 Sep 4. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C584510 | defactinib |
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| 18 months |
| Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples | 18 months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Nashville | Tennessee | 37203 | United States |
| Pfizer Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |