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Completed

NCT Number: NCT00787033

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-04554878

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Verastem, Inc.

Industry

Registry information

Official study 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

Acronym: B0761001

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Nov 7, 2008
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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