A Study Of PF-03732010 In Patients With Advanced Solid Tumors

A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors

P-cadherin may play a part in tumor growth; PF-03732010 is a new drug that inhibits P-cadherin. This study will test how well the drug is tolerated, and what effects there might be. Blood will also be taken to measure the amount of drug in blood.

Inclusion Criteria:

• Advanced solid tumors refractory to (or intolerant of) established therapy known to provide clinical benefit, or for which there is no standard therapy
• Age >= 18 years of age
• Adequate bone marrow function as defined by: absolute neutrophil count (ANC) ≥1500/uL, hemoglobin ≥ 9 g/dL, platelets > 100,000/uL
• Adequate liver function as defined by: bilirubin < 1.5 x ULN, AST, ALT and ALP < 2.5 x ULN, or < 5 x ULN with documented liver and/or bone metastases
• Serum creatinine < 1.5 x ULN
• ECOG status 0-1
• Availability of biopsy tumor tissue (or fine needle aspirate) for testing of P-cadherin expression
• Tumor tissue (or fine needle aspirate) showing over-expression of P-cadherin
• Must be able to give written informed consent
• Be able to comply with scheduled study visits, treatment plans, laboratory tests and other procedures

Exclusion Criteria:

• Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of study entry
• Patients with carcinomatous meningitis or untreated brain metastases.
• History of significant low platelet count, and/or bleeding disorders, requiring medical or surgical intervention
• History of significant bleeding episodes within 6 months, unless the source of bleeding has been resected