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

Study Overview
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Brief Summary
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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).

Official Title
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An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer

Conditions
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Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Rovalpituzumab tesirine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: Rovalpituzumab tesirine<br>Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle | Drug: Rovalpituzumab tesirine<br>* Intravenous<br>|
| Experimental: Part B: Rovalpituzumab tesirine<br>Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD). | Drug: Rovalpituzumab tesirine<br>* Intravenous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with dose-limiting toxicities (DLT) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. | Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (DOR) | DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 
| Overall survival (OS) | OS is defined as the time from the date of first dose to the date of death. | First dose of study drug through long-term follow up; Up to 24 months after participant's first dose. | 
| Progression-free survival (PFS) | PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 
| Clinical benefit rate (CBR) | CBR is defined as the proportion of participants whose overall response is either CR, PR, or Stable Disease (SD) according to RECIST version 1.1. | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer