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

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Gemcitabine

Criteria

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