A Study Of PF-04449913 In Select Hematologic Malignancies

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hematologic Malignancies

Treatments: Drug: PF-04449913

Study type: Interventional

Funder types: Industry

Identifiers

NCT00953758

B1371001

2009-011285-29 (EudraCT Number)

Details and patient eligibility

About

This study examines the effect of a small molecule inhibitor to the Sonic Hedgehog pathway on select hematologic malignancies.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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47 participants in 1 patient group

1

Experimental group

Treatment:

Drug: PF-04449913