Clinical trial NCT03086239: A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
Official title: An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Small Cell Lung Cancer
Keywords: Advanced, Recurrent Small Cell Lung Cancer
Small Cell Lung Cancer
Rovalpituzumab tesirine
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with dose-limiting toxicities (DLT)
timeFrame: Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
measure: Objective Response Rate (ORR)
timeFrame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
measure: Overall survival (OS)
timeFrame: First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
measure: Progression-free survival (PFS)
timeFrame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
measure: Clinical benefit rate (CBR)
timeFrame: First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Ctr Hosp East /ID# 161432
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 161430
state: Fukuoka
city: Osakasayama-shi
country: Japan
facility: Kinki University -Osakasayama Campus /ID# 161431
state: Osaka
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital /ID# 161429
state: Tokyo
city: Wakayama
country: Japan
facility: Wakayama Medical University /ID# 161428
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Udagawa H, Akamatsu H, Tanaka K, Takeda M, Kanda S, Kirita K, Teraoka S, Nakagawa K, Fujiwara Y, Yasuda I, Okubo S, Shintani M, Kosloski MP, Scripture C, Tamura T, Okamoto I. Phase I safety and pharmacokinetics study of rovalpituzumab tesirine in Japanese patients with advanced, recurrent small cell lung cancer. Lung Cancer. 2019 Sep;135:145-150. doi: 10.1016/j.lungcan.2019.07.025. Epub 2019 Jul 24.
citation: Tanaka K, Isse K, Fujihira T, Takenoyama M, Saunders L, Bheddah S, Nakanishi Y, Okamoto I. Prevalence of Delta-like protein 3 expression in patients with small cell lung cancer. Lung Cancer. 2018 Jan;115:116-120. doi: 10.1016/j.lungcan.2017.11.018. Epub 2017 Nov 22.