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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT01268293
Eligibility Criteria:
Inclusion Criteria
* Subjects with histologically and/or cytologically diagnosis of solid tumor
* Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
* Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
* Subjects who completed previous anti-tumor therapy before at least 4 weeks
* Subjects who are 20 years or older
* Subjects with 0 to 1 of Performance Status
* Subjects agree to be hospitalized for DLT observation
* Subjects with adequate organ functions
* Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
* Agree to participate in this study in writing based on voluntary will
Exclusion Criteria
* Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
* Subjects with the severe complication or disease history
* Subjects unable to take oral medication.
* Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
* Scheduled for surgery during the projected course of the study.
* Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
* Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
* Pregnant or nursing subjects
* Subjects who are participating in another clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01268293
Study Brief:
Protocol Section:
NCT01268293