A Long-Term Study of Rovalpituzumab Tesirine

Completed · Phase 2

Conditions studied: Cancer

In brief

The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.

Key facts

Study ID

NCT03543358

Run by

AbbVie

People needed

3

Starts

2018-09-10

Expected to finish

2019-11-26

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects not previously enrolled in a rovalpituzumab tesirine study.

Where it is running

• Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818 — Tucson, Arizona, United States
• City of Hope National Medical Center /ID# 204885 — Duarte, California, United States
• Univ of Pittsburgh Med Ctr /ID# 204763 — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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