A Long-Term Study of Rovalpituzumab Tesirine

AbbVie

Status and phase: Completed; Phase 2

Conditions: Cancer

Treatments: Drug: rovalpituzumab tesirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03543358

M16-291

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Arm A: Post-Treatment Follow-Up/Optional Retreatment

Experimental group

Description:

Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period.

Treatment:

Drug: rovalpituzumab tesirine

Drug: rovalpituzumab tesirine

Arm B: Continued Treatment

Experimental group

Description:

Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.

Treatment:

Drug: rovalpituzumab tesirine

Drug: rovalpituzumab tesirine