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

NCT ID: NCT00557505

Last Updated: 2012-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-02-28

Brief Summary

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PF-03732010

Single Arm study

Group Type: EXPERIMENTAL

PF-03732010

Intervention Type: DRUG

IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.

Interventions

PF-03732010

IV infusion. Escalating dose levels, starting at 0.5 mg/kg to Maximum Tolerated Dose. Cycle length of 4 weeks for first cycle, and 2 weekly for subsequently cycles was originally explored, yet based on emerging PK data the Cycle 1 duration is 2 weeks and then weekly. Number of Cycles: Until Progression or unacceptable toxicity develops.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Pfizer Investigational Site

Parkville, Victoria, Australia

Pfizer Investigational Site

Seoul, , South Korea

Countries

United States; Australia; South Korea

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9301001&StudyName=A%20Study%20Of%20PF-03732010%20In%20Patients%20With%20Advanced%20Solid%20Tumors

To obtain contact information for a study center near you, click here.

Other Identifiers

A9301001

Identifier Type: -

Identifier Source: org_study_id