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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: PF-03732010

Study type

Interventional

Funder types

Industry

Identifiers

NCT00557505

A9301001

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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