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A Study Of PF-04449913 In Select Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00953758
First received: August 4, 2009
Last updated: December 8, 2013
Last verified: December 2013
  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:


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: 47
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

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: December 8, 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

ClinicalTrials.gov processed this record on November 25, 2014