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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 ULN, or

- Serum creatinine

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00557505
Pfizer
Completed
A Study Of PF-03732010 In Patients With Advanced Solid Tumors

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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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Neoplasms
Drug: 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.
Experimental: PF-03732010
Single Arm study
Intervention: Drug: PF-03732010
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Korea, Republic of,   United States
 
 
NCT00557505
A9301001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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