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

Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086239
• Other study ID #: SCRX001-008
• Status: Completed
• Phase: Phase 1
• Start date: April 28, 2017
• Est. completion date: August 20, 2018

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 20, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Drug:
• Rovalpituzumab tesirine
Intravenous

Locations

Country	Name	City	State
Japan	National Cancer Center Hospital /ID# 161429	Chuo-ku	Tokyo
Japan	Kyushu University Hospital /ID# 161430	Fukuoka-shi	Fukuoka
Japan	National Cancer Ctr Hosp East /ID# 161432	Kashiwa-shi	Chiba
Japan	Kinki University -Osakasayama Campus /ID# 161431	Osakasayama-shi	Osaka
Japan	Wakayama Medical University /ID# 161428	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.