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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03086239
• Collaborator: (none)
• Enrollment: 29
• Locations: 5
• Arms: 2
• Actual Duration (Months): 15.7
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Small Cell Lung Cancer	Drug: Rovalpituzumab tesirine	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 29 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
• Actual Study Start Date: Apr 28, 2017
• Actual Primary Completion Date: Jan 30, 2018
• Actual Study Completion Date: Aug 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: Rovalpituzumab tesirine Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle	Drug: Rovalpituzumab tesirine; Intravenous
Experimental: Part B: 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).	Drug: Rovalpituzumab tesirine; Intravenous

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Ctr Hosp East /ID# 161432	Kashiwa-shi	Chiba	Japan	277-8577
2	Kyushu University Hospital /ID# 161430	Fukuoka-shi	Fukuoka	Japan	812-8582
3	Kinki University -Osakasayama Campus /ID# 161431	Osakasayama-shi	Osaka	Japan	589-8511
4	National Cancer Center Hospital /ID# 161429	Chuo-ku	Tokyo	Japan	104-0045
5	Wakayama Medical University /ID# 161428	Wakayama		Japan	641-8510

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: AbbVie Inc., AbbVie

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT03086239
• Other Study ID Numbers: SCRX001-008
• First Posted: Mar 22, 2017
• Last Update Posted: Aug 3, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by AbbVie: Advanced, Recurrent Small Cell Lung Cancer; Small Cell Lung Cancer; Rovalpituzumab tesirine; Cancer
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma

Study Results

No Results Posted as of Aug 3, 2021