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

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ClinicalTrials.gov Identifier: NCT01286467
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: PF-04449913 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: 1 Drug: PF-04449913
Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles



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

Secondary Outcome Measures :
  1. 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 ]
  2. Hedgehog biomarker modulation [ Time Frame: 26 months ]
  3. Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of PF-04449913 [ Time Frame: 26 months ]
  4. QTc interval [ Time Frame: 26 months ]
  5. Objective tumor response [ Time Frame: 26 months ]
  6. Progression free survival [ Time Frame: 26 months ]
  7. Time to progression [ Time Frame: 26 months ]
  8. Duration of response [ Time Frame: 26 months ]


Information from the National Library of Medicine

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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

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

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

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