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A Study Of PF-04554878 In Patients With Advanced Non-Hematologic Malignancies (B0761001)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.
ClinicalTrials.gov Identifier:
NCT00787033
First received: November 5, 2008
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Drug: PF-04554878
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Verastem, Inc.:

Primary Outcome Measures:
  • Recommended Phase 2 Dose [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT) [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor metabolic response [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • FAK-related biomarkers in tumor biopsies and blood [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: December 2008
Study Completion Date: February 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dose escalation study with Expansion Cohorts at RP2D and Schedule
Drug: PF-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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787033

Locations
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
Verastem, Inc.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT00787033     History of Changes
Other Study ID Numbers: B0761001
Study First Received: November 5, 2008
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Verastem, Inc.:
Focal Adhesion Kinase; Advanced Non-Hematologic Malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014