A Study Of PF-04449913 In Select Hematologic Malignancies - Full Text View

Purpose

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

Condition	Intervention	Phase
Hematologic Malignancies	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 Hematologic Malignancies

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 (Phase 1a) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Modulation of Pharmacodynamic biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
QTc interval [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	March 2010
Study Completion Date:	February 2013
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: PF-04449913 Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953758

Locations

United States, California
Pfizer Investigational Site
La Jolla, California, United States, 92093
Pfizer Investigational Site
La Jolla, California, United States, 92037
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
Italy
Pfizer Investigational Site
Bologna, Italy, 40138

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00953758 History of Changes
Other Study ID Numbers:	B1371001
Study First Received:	August 4, 2009
Last Updated:	May 17, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013