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.

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