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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT02573467
Eligibility Criteria:
Inclusion Criteria:
* Patients who completed the core study
* Written informed consent must be obtained before any extension study assessment is performed.
* Able to communicate well with the investigator.
* Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
Exclusion Criteria:
* Women who are pregnant
* Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose.
* Current use of prohibited treatments
* History of severe hypersensitivity reaction in the core study
* History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject's overall status, prevent the subject from entering the extension study
* Clinically significant abnormal liver function tests
* Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
36 Years
Study:
NCT02573467
Study Brief:
Protocol Section:
NCT02573467