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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Hematologic Malignancies

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

First cycle dose limiting toxicities (Phase 1a)

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1371001

NCT ID:

NCT00953758

Start Date:

March 2010

Completion Date:

February 2013

Related Keywords:

  • Hematologic Malignancies
  • Chronic Myeloid Leukemia Myelofibrosis Myelodysplastic Syndrome Acute myeloid Leukemia Hedgehog inhibitor
  • Neoplasms
  • Hematologic Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteFederal Way, Washington  98003