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