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

Stopped early · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00437203

Run by

Pfizer

People needed

43

Starts

2006-12-01

Expected to finish

2011-04-01

Last updated by the study team

2012-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — East Melbourne, Victoria, Australia

Full record on ClinicalTrials.gov

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