Eligibility Module

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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 @ 2:06 AM
Ignite Modification Date: 2025-12-25 @ 2:06 AM
NCT ID: NCT00641160
Eligibility Criteria: Inclusion Criteria: * capable of understanding study requirements and able to provide Informed Consent * diagnosed with a non-hematologic malignancy for which there are no currently accepted therapies * life expectancy at least 3 months * agreement to use medically acceptable contraception throughout the study * willing and able to comply with the protocol requirements Exclusion Criteria: * currently receiving systemic treatment for malignancy * not yet recovered from the toxicity of prior therapies * platelet count \< 100,000 cells/mm3 within 7 days prior to study entry * ANC \< 1500 cells/mm3 within 7 days prior to study entry * hemoglobin \< 8.5 g/dL within 7 days prior to study entry * AST and/or ALT \> 2.5 X ULN within 7 days prior to study entry * total bilirubin \> 1.5 X ULN within 7 days prior to study entry * creatinine clearance \< 60 mL/min (Cockroft-Gault formula) within 7 days prior to study entry * receipt of any investigational therapy within 3 weeks prior to study entry * known history of HIV, HBV, and/or HCV infection * clinically relevant active infection or serious co-morbid medical condition at study entry * major surgery within 4 weeks prior to study entry * other malignancy within 3 year prior to study entry * pregnant or breast-feeding * presence of a concomitant disease or condition which, in the opinion of the Investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT00641160
Study Brief:
Protocol Section: NCT00641160