NCT00787033

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started Dec 2008

Typical duration for phase_1 cancer

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 25, 2017

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

November 5, 2008

Last Update Submit

January 24, 2017

Conditions

Cancer

Keywords

Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies

Outcome Measures

Primary Outcomes (2)

  • Recommended Phase 2 Dose

    18 months

  • Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT)

    18 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

1

EXPERIMENTAL

Dose escalation study with Expansion Cohorts at RP2D and Schedule

Drug: PF-04554878

Interventions

PF-04554878DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02215, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26334219DERIVED

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

defactinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 7, 2008

Study Start

December 1, 2008

Primary Completion

March 1, 2011

Study Completion

February 1, 2012

Last Updated

January 25, 2017

Record last verified: 2013-03

Locations

US(4)CA(1)