A Study Of PF-03732010 In Patients With Advanced Solid Tumors
NCT00557505
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | A Study Of PF-03732010 In Patients With Advanced Solid Tumors | |||
Official Title ICMJE | A Phase 1 Pharmacokinetic And Pharmacodynamic Study Of PF-03732010 In Patients With Advanced Solid Tumors | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Neoplasms | |||
Intervention ICMJE | 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. | |||
Study Arms ICMJE | Experimental: PF-03732010
Single Arm study Intervention: Drug: PF-03732010 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 43 | |||
Original Enrollment ICMJE | 60 | |||
Actual Study Completion Date ICMJE | February 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Korea, Republic of, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00557505 | |||
Other Study ID Numbers ICMJE | A9301001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |