A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
- Registration Number
- NCT03086239
- Lead Sponsor
- AbbVie
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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.
- No prior exposure to a pyrrolobenzodiazepine (PBD)-based drug.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Rovalpituzumab tesirine Rovalpituzumab tesirine Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle Part B: Rovalpituzumab tesirine Rovalpituzumab tesirine Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (5)
National Cancer Ctr Hosp East /ID# 161432
🇯🇵Kashiwa-shi, Chiba, Japan
Kyushu University Hospital /ID# 161430
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kinki University -Osakasayama Campus /ID# 161431
🇯🇵Osakasayama-shi, Osaka, Japan
Wakayama Medical University /ID# 161428
🇯🇵Wakayama, Japan
National Cancer Center Hospital /ID# 161429
🇯🇵Chuo-ku, Tokyo, Japan