A Study Of PF-04449913 In Select Hematologic Malignancies

December 8, 2013 updated by: Pfizer

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF 04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Hematologic Malignancies

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
  • United States
    • California
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92093
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030-4009
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with select advanced hematologic malignancies who are refractory, resistant or intolerant to prior therapies. They may be newly diagnosed and previously untreated, but not eligible for standard treatment options, or for whom standard therapies are not anticipated to result in a durable response.
  • ECOG performance status 0 to 2
  • Adequate organ function

Exclusion Criteria:

  • Patients with active CNS disease
  • Patient with active malignancy with the exception of basal cell carcinoma, non melanoma skin cancer, carcinoma in situ cervical or skin cancer
  • Active GVHD other than Grade 1 skin involvement
  • Known malabsorption syndrome
  • Patient has an active, life threatening or clinically significant uncontrolled systemic infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PF-04449913
Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First cycle dose limiting toxicities (Phase 1a)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Modulation of Pharmacodynamic biomarkers
Time Frame: 12 months
12 months
Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913
Time Frame: 12 months
12 months
Overall response (OR), time to progression (TTP), duration of response and progression-free survival (PFS) as defined by disease specific clinical practice guidelines
Time Frame: 12 months
12 months
QTc interval
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 4, 2009

First Submitted That Met QC Criteria

August 5, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 8, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1371001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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