A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

AbbVie

Status and phase: Completed; Phase 1

Conditions: Small Cell Lung Cancer

Treatments: Drug: Rovalpituzumab tesirine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03086239

SCRX001-008

Details and patient eligibility

About

This is a Japanese, multicenter, open-label, dose-escalation study. This is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in Japanese participants with advanced small cell lung cancer (SCLC).

Enrollment: 29 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (SCLC) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic, hepatic and renal function.

Exclusion criteria

• No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Part A: Rovalpituzumab tesirine

Experimental group

Description:

Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle

Treatment:

Drug: Rovalpituzumab tesirine

Part B: Rovalpituzumab tesirine

Experimental group

Description:

Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).

Treatment:

Drug: Rovalpituzumab tesirine