Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT00557505
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00557505
Study Brief:
Protocol Section:
NCT00557505