Small Cell Lung Cancer
Conditions
Keywords
Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer
Brief summary
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).
Interventions
Intravenous
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLT) | Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1) | DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first. |
| Objective Response Rate (ORR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 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. |
| Overall survival (OS) | First dose of study drug through long-term follow up; Up to 24 months after participant's first dose. | OS is defined as the time from the date of first dose to the date of death. |
| Progression-free survival (PFS) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first. |
| Clinical benefit rate (CBR) | First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose. | 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. |
Countries
Japan
Outcome results
None listed