A Long-Term Study of Rovalpituzumab Tesirine

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.