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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00787033

Acronym

B0761001

Enrollment

Registered

2008-11-07

Start date

2008-12-31

Completion date

2012-02-29

Last updated

2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies

Brief 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.

Interventions

DRUGPF-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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recommended Phase 2 Dose	18 months
Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)	18 months

Secondary

Measure	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	18 months
Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples	18 months

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026