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 @ 7:49 PM
Ignite Modification Date:
2025-12-24 @ 7:49 PM
NCT ID:
NCT01491204
Eligibility Criteria:
Inclusion Criteria:
1. Patients must histologically or cytologically be diagnosed to have an advanced solid cancer.
2. Patients have progressive disease in spite of standard anti-cancer therapy or are not expected to benefit or prolong survival from any existing anti-cancer therapy
3. Patients who received chemotherapy, radiation therapy, surgery must have passed at least 4weeks since the final treatment and must have fully recovered from the toxicities Patients treated by Nitrosoureas or Mitomycin C must wait 6 weeks before becoming eligible.
4. ECOG performance status ≤ 2
5. Life expectancy ≥ 12 weeks
6. Patients have proper bone marrow, kidney, liver function and patients do not have remarkable dysfunction of heart and lung: WBC≥4000/mm3; Platelet ≥100,000/mm3; Hemoglobin≥9.0g/dL; ANC≥ 1,500 /mm3; Creatinine ≤ 1.5mg/dL; AST/ALT/ALP ≤ 3 X the upper limit of normal; Total bilirubin ≤2.0mg/dL \*AST/ALT/ALP ≤ 3 X the upper limit of normal but \<5 if liver or bone metastasis is present
Exclusion Criteria:
1. Patients with blood tumor (ex, leukemia), uncontrolled infectious disease, neurologic disorders, metastasis to CNS or ileus (patients requiring non-oral administration of anti-biotics to treat active bacterial infection are nor eligible, but patients can participate in the trial after complete eradication or control of the infection)
2. Patients who have received bone marrow transplant or are to receive bone marrow transplant.
3. Patients who had the medical history of atrial or ventricular arrhythmia or congestive heart failure or received medical treatment for myocardial infarction within 6 months.
4. Pregnant or lactating or with childbearing potential without use of adequate contraception (in case of men, appropriate contraception is required).
5. Patients who are on PGP inhibitor such as Cyclosporine or Verapamil which are prohibited.: Such patients may qualify after two-week wash-out period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
70 Years
Study:
NCT01491204
Study Brief:
Protocol Section:
NCT01491204