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

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

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

Type of Study:


Study Design:

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD)

Outcome Time Frame:

Baseline up to end of treatment (EOT) or withdrawal assessed up to Day 7 of last cycle

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

February 2011

Related Keywords:

  • Neoplasms
  • Neoplasms



Pfizer Investigational Site Kingston, Pennsylvania  18704-5535