PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

Phase I Study of PF-00477736 With Gemcitabine In Patients With Advanced Solid Malignancies

To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.

The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient on study continued treatment until 19 April 2011 when stopped for complete response. Premature closure was not prompted by any safety or efficacy concerns.

Inclusion Criteria:

• Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.
• ECOG performance status 0 or 1.
• Adequate blood cell counts, kidney function and liver function.

Exclusion Criteria:

• Prior treatment with gemcitabine.
• Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
• NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
• NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.
• Known human immunodeficiency virus (HIV) seropositivity.
• Concurrent treatment with anticoagulants or known coagulopathy