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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01286467
First Posted: January 31, 2011
Last Update Posted: June 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
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): NCT01286467


Locations
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
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286467     History of Changes
Other Study ID Numbers: B1371002
First Submitted: January 14, 2011
First Posted: January 31, 2011
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Pfizer:
PF-04449913
Hedgehog Inhibitor
Solid tumor
Pharmacokinetics
Safety
Pharmacodynamics