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NCT00787033 Clinical Trial

A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies

Cancer Clinical Trial

— B0761001  

Official title:
A Phase 1, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00787033
Other study ID # B0761001
Secondary ID
Status Completed
Phase Phase 1
First received November 5, 2008
Last updated January 24, 2017
Start date December 2008
Est. completion date February 2012

Study information
Verified date March 2013
Source Verastem, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date February 2012
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with advanced non-hematologic malignancies.

- Adequate organ function, including bilirubin less than 1.5 x ULN, and ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.

Exclusion Criteria:

- Clinically significant gastrointestinal abnormalities, requirement for systemic anticoagulants or potent CYP 2C8 inhibitors, and history of clinically significant cardiac or pulmonary disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-04554878
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

Locations
Country Name City State
Canada Pfizer Investigational Site Toronto Ontario
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Verastem, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recommended Phase 2 Dose 18 months
Primary Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT) 18 months
Secondary Tumor metabolic response 18 months
Secondary PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters 18 months
Secondary FAK-related biomarkers in tumor biopsies and blood 18 months
Secondary Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples 18 months
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