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A Study Of PF-04449913 In Select Hematologic Malignancies

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
La Jolla, California, 92037 United States
Contact
1-800-718-1021
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

NCT00953758
Pfizer
Completed
A Study Of PF-04449913 In Select Hematologic Malignancies

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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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hematologic Malignancies
Drug: PF-04449913
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Experimental: 1
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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.
 
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy,   United States
 
 
NCT00953758
B1371001
No
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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