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Trial record 13 of 109 for:    hedgehog

A Study Of PF-04449913 In Select Hematologic Malignancies

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

Tracking Information
First Submitted Date  ICMJE August 4, 2009
First Posted Date  ICMJE August 6, 2009
Last Update Posted Date December 10, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
First cycle dose limiting toxicities (Phase 1a) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
  • To determine the Maximum Tolerated Dose (MTD) and recommended Phase 2 dose of PF-04449913 [ Time Frame: 12 months ]
  • 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 ]
Change History Complete list of historical versions of study NCT00953758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2011)
  • Modulation of Pharmacodynamic biomarkers [ Time Frame: 12 months ]
  • Area under the plasma concentration curve (AUC) of PF-04449913. Maximum plasma concentration of PF-04449913 [ Time Frame: 12 months ]
  • 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 ]
  • QTc interval [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2009)
  • 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 ]
  • Pharmacodynamic biomarker modulation (Phase 1a). [ Time Frame: 12 months ]
  • Pharmacokinetic parameters of PF-04449913 (Phase 1a). [ Time Frame: 12 months ]
  • 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 ]
  • QTc interval (Phase 1a). [ Time Frame: 12 months ]
  • 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 ]
  • 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 ]
  • Pharmacodynamic biomarker modulation (Phase 1b). [ Time Frame: 9 months ]
  • Pharmacokinetic parameters of PF-04449913 and dasatinib (Phase 1b). [ Time Frame: 9 months ]
  • Overall Response, TTP, duration of response and PFS, as defined by clinical practice guidelines for CML (Phase 1b). [ Time Frame: 9 months ]
  • QTc interval (Phase 1b). [ Time Frame: 9 months ]
  • 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 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of PF-04449913 In Select Hematologic Malignancies
Official Title  ICMJE 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
Brief Summary This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hematologic Malignancies
Intervention  ICMJE Drug: PF-04449913
Escalating doses of PF-04449913 administered as tablets PO QD continuously in 28 day cycles
Study Arms Experimental: 1
Intervention: Drug: PF-04449913
Publications * Martinelli G, Oehler VG, Papayannidis C, Courtney R, Shaik MN, Zhang X, O'Connell A, McLachlan KR, Zheng X, Radich J, Baccarani M, Kantarjian HM, Levin WJ, Cortes JE, Jamieson C. Treatment with PF-04449913, an oral smoothened antagonist, in patients with myeloid malignancies: a phase 1 safety and pharmacokinetics study. Lancet Haematol. 2015 Aug;2(8):e339-46. doi: 10.1016/S2352-3026(15)00096-4. Epub 2015 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2013)
47
Original Estimated Enrollment  ICMJE
 (submitted: August 5, 2009)
94
Actual Study Completion Date February 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00953758
Other Study ID Numbers  ICMJE B1371001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013

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