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

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: PF-04554878

• Registration Number: NCT00787033
• Lead Sponsor: Verastem, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-07
• Study Start: 2008-12
• Primary Completion: 2011-03
• Study Completion: 2012-02
• Status Verified: 2013-03
• Last Update Submitted: 2017-01-24
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	PF-04554878	Dose escalation study with Expansion Cohorts at RP2D and Schedule

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
FAK-related biomarkers in tumor biopsies and blood	18 months
Tumor metabolic response	18 months
Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples	18 months
PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters	18 months

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Toronto, Ontario, Canada