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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT01401504
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor
* Patient meets at least 1 of the following criteria:
* Disease progression despite standard therapies
* No standard therapies are available or such therapies are not anticipated to result in a durable response
* Standard therapies are considered unsuitable or have been refused
* Life expectancy \> 12 weeks
* Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing
Exclusion Criteria:
* Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias)
* Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing
* Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study
* Use of an investigational drug or device within 21 days prior to the scheduled initial dosing
* Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing
* A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
* Known history of a positive test for human immunodeficiency virus (HIV) infection
* Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01401504
Study Brief:
Protocol Section:
NCT01401504