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

August 4, 2009
December 8, 2013
March 2010
September 2012   (final data collection date for primary outcome measure)
First cycle dose limiting toxicities (Phase 1a) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose of PF-04449913 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • To determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose of PF-04449913 when administered in combination with dasatinib [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00953758 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], timing, seriousness, and relatedness of adverse events; vital signs and laboratory test abnormalities (Phase 1a). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic biomarker modulation (Phase 1a). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of PF-04449913 (Phase 1a). [ 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 (Phase 1a). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • QTc interval (Phase 1a). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Variations in genes and/or gene products which influence Hedgehog signaling pathways in patient samples in response to treatment with PF-04449913 (Phase 1a). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Type, incidence, severity graded by the NCI Common Terminology Criteria for Adverse Events, timing, seriousness, and relatedness of adverse events; vital signs and laboratory test abnormalities of PF-04449913 in combination with dasatinib (Phase 1b) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Pharmacodynamic biomarker modulation (Phase 1b). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameters of PF-04449913 and dasatinib (Phase 1b). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Overall Response, TTP, duration of response and PFS, as defined by clinical practice guidelines for CML (Phase 1b). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • QTc interval (Phase 1b). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Variations in genes and/or gene products which influence Hedgehog signaling pathways in patient samples in response to treatment with PF-04449913 (Phase 1b). [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study Of PF-04449913 In Select Hematologic Malignancies
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

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hematologic Malignancies
Drug: PF-04449913
Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles
Experimental: 1
Intervention: Drug: PF-04449913
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
February 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy
 
NCT00953758
B1371001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP