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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT01284192
Eligibility Criteria:
Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor or B-cell lymphoma and 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
* Able to take oral medications
* Life expectancy \> 12 weeks
* For the expansion cohort of the study, all subjects must be confirmed to be positive for ALK gene abnormalities
* Subjects with stable brain metastasis will be allowed
Exclusion Criteria:
* Active central nervous system (CNS) metastases or leptomeningeal involvement as assessed through medical history review and physical examination (dose escalation subjects only)
* Known history of a positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
* Known hereditary or acquired immunodeficiency syndrome or human immunodeficiency virus (HIV) infection
* Cardiac arrhythmias \> Grade 1 using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.03
* Class 3 or 4 New York Heart Association congestive heart failure, acute coronary syndrome, myocardial infarction or cerebrovascular accident within 6 months prior to Cycle 1, Day 1
* Inadequate bone marrow, renal, and/or hepatic function
* Confirmed active peptic ulcer disease or history of gastrointestinal bleeding within the past 3 months
* Known history of long QT syndrome
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01284192
Study Brief:
Protocol Section:
NCT01284192