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A Study Of PF-04449913 Administered Alone In Select Solid Tumors

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: January 14, 2011
Last updated: June 5, 2013
Last verified: June 2013
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.

Condition Intervention Phase
Solid Tumors Drug: PF-04449913 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-04449913, An Oral Hedgehog Inhibitor, Administered As Single Agent In Select Solid Tumors

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • First cycle dose limiting toxicities (DLTs) [ Time Frame: 10 months ]

Secondary Outcome Measures:
  • Type, incidence, severity (graded by the national cancer institute [NCI] common criteria for Adverse events [CTCAE], timing, seriousness and relatedness of adverse events to PF-04449913 [ Time Frame: 26 months ]
  • Hedgehog biomarker modulation [ Time Frame: 26 months ]
  • Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of PF-04449913 [ Time Frame: 26 months ]
  • QTc interval [ Time Frame: 26 months ]
  • Objective tumor response [ Time Frame: 26 months ]
  • Progression free survival [ Time Frame: 26 months ]
  • Time to progression [ Time Frame: 26 months ]
  • Duration of response [ Time Frame: 26 months ]

Enrollment: 23
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-04449913
Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological diagnosis of advanced/metastatic solid tumor
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function

Exclusion Criteria:

  • Patients with known symptomatic brain metastases requiring steroids
  • Current active treatment on another clinical trial
  • Major surgery or radiation therapy within 4-weeks of starting study treatment
  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 identifier: NCT01286467

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT01286467     History of Changes
Other Study ID Numbers: B1371002
Study First Received: January 14, 2011
Last Updated: June 5, 2013

Keywords provided by Pfizer:
Hedgehog Inhibitor
Solid tumor
Pharmacodynamics processed this record on September 21, 2017