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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01286467
First received: January 14, 2011
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • First cycle dose limiting toxicities (DLTs) [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • Hedgehog biomarker modulation [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of PF-04449913 [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • QTc interval [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Objective tumor response [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 26 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 26 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01286467     History of Changes
Other Study ID Numbers: B1371002
Study First Received: January 14, 2011
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013