Clinical trial NCT00787033: A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies
Lead sponsor: Verastem, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recommended Phase 2 Dose
timeFrame: 18 months
measure: Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)
timeFrame: 18 months
Secondary outcomes:
measure: Tumor metabolic response
timeFrame: 18 months
measure: PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters
timeFrame: 18 months
measure: FAK-related biomarkers in tumor biopsies and blood
timeFrame: 18 months
measure: Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples
timeFrame: 18 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.