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 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 12:26 AM
NCT ID:
NCT03543358
Eligibility Criteria:
Inclusion Criteria:
* Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.
* Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.
For subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:
* Tolerated their initial 2 doses of rovalpituzumab tesirine.
* Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.
* Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.
* Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate hematologic, kidney, and liver function, per protocol.
* In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.
Exclusion Criteria:
* Subjects not previously enrolled in a rovalpituzumab tesirine study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03543358
Study Brief:
Protocol Section:
NCT03543358