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

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ClinicalTrials.gov Identifier: NCT00787033
Recruitment Status : Completed
First Posted : November 7, 2008
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Drug: PF-04554878 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : February 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Recommended Phase 2 Dose [ Time Frame: 18 months ]
  2. Overall safety profile of PF-04554878, including Dose-Limiting Toxicity (DLT) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Tumor metabolic response [ Time Frame: 18 months ]
  2. PF-04554878 pharmacokinetic (PK) parameters and Midazolam PK parameters [ Time Frame: 18 months ]
  3. FAK-related biomarkers in tumor biopsies and blood [ Time Frame: 18 months ]
  4. Molecular profiling (genomics data) based on the optional studies with whole blood and/or tumor samples [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT00787033     History of Changes
Other Study ID Numbers: B0761001
First Posted: November 7, 2008    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: March 2013

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

Additional relevant MeSH terms:
Neoplasms