A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
Sponsored by Verastem, Inc.
About this trial
Last updated 8 years ago
Study ID
B0761001
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 13 years ago
What is this trial about?
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.
What are the participation requirements?
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