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A Study Of PF-04449913 In Select Hematologic Malignancies

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. Identifier: NCT00953758
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: PF-04449913 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 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 Hematologic Malignancies
Study Start Date : March 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : February 2013

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

Primary Outcome Measures :
  1. First cycle dose limiting toxicities (Phase 1a) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Modulation of Pharmacodynamic biomarkers [ Time Frame: 12 months ]
  2. Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913 [ Time Frame: 12 months ]
  3. 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 ]
  4. QTc interval [ Time Frame: 12 months ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00953758

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United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
La Jolla, California, United States, 92093
Pfizer Investigational Site
San Diego, California, United States, 92103
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030-4009
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98109-1023
Pfizer Investigational Site
Bologna, Italy, 40138
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00953758     History of Changes
Other Study ID Numbers: B1371001
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Pfizer:
Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor

Additional relevant MeSH terms:
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