A Study Of PF-04449913 In Select Hematologic Malignancies

NCT00953758

Last updated date
Study Location
Pfizer Investigational Site
La Jolla, California, 92037, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hematologic Malignancies
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
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  ICMJE 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  ICMJE 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  ICMJE 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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
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