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:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT01028859
Eligibility Criteria:
Inclusion Criteria:
* 20\~75 years
* Histologically or cytologically confirmed solid tumors that have failed to standard therapy or for which no life prolonging treatment exists
* ECOG PS 0-2
* Life expectancy 12 weeks
* Hematopoietic: ANC ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Hemoglobin ≥ 9.0g/dL, Prothrombin time, Activated partial thromboplastin time: normal range
* Hepatic: total bilirubin ≤ 1.5×ULN(except Gilbert's syndrome patients), AST, ALT ≤ 3.0×ULN(AST, ALT ≤ 5.0×ULN in case of liver metastases)
* Renal: serum creatinine ≤ 1.5×ULN or Creatinine clearance ≥ 60 mL/min
* Signed a written informed consent
Exclusion Criteria:
* Brain or Leptomeningeal metastases
* History of Ischemic heart disease(e.g., myocardial infarction, unstable angina pectoris) or Clinically significant heart disease such as NYHA Class III and IV Congestive atrial arrhythmias, within 6 months prior to first dose of study drug
* Stable angina pectoris shown symptoms within 6 months prior to first dose of study durg, or Clinically significant abnormality on EKG or echocardiogram(e.g., LVEF \< 50% or clinically significant heart wall abnormality or heart muscle damage)
* Cerebrovascular disease such as stroke
* Grade 2 or greater motor or sensory peripheral neuropathy
* Clinically significant eye diseases(e.g., Glaucoma or Proliferative diabetic retinopathy, Atrophic macular degeneration), or other clinically significant abnormality on screening visit
* Uncontrolled hypertension(greater than 150 mmHg systolic anc 100 mmHg diastolic regardless of medication)
* acute infection or blooding tendencies that would preclude study compliance
* Serious vascular disease such as Aortic aneurysm
* Other psychiatric disorders or other conditions that would preclude study compliance
* Receiving anticoagulation with warfarin, heparin, etc.
* Receiving antitumor therapy(surgery, immunotherapy or chemotherapy) within 4 weeks prior to first dose of study drug(6 weeks for nitrosoureas and mitomycin C, 2 weeks for radiation therapy)
* Other concurrent antitumor therapy
* History of Serious hypersensitivity or allergy
* Pregnant or nursing, active serum pregnancy test. Fertile patients must use effective contraception
* Participation in a clinical trial within 4 weeks of first dose of study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01028859
Study Brief:
Protocol Section:
NCT01028859