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

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Rovalpituzumab tesirine
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Ctr Hosp East /ID# 161432
  • Kyushu University Hospital /ID# 161430
  • Kinki University -Osakasayama Campus /ID# 161431
  • National Cancer Center Hospital /ID# 161429
  • Wakayama Medical University /ID# 161428

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Part A: Rovalpituzumab tesirine

Part B: Rovalpituzumab tesirine

Arm Description

Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle

Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of response (DOR)
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
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.
Overall survival (OS)
OS is defined as the time from the date of first dose to the date of death.
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.
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.

Full Information

First Posted
March 17, 2017
Last Updated
July 28, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03086239
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
January 30, 2018 (Actual)
Study Completion Date
August 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Advanced, Recurrent Small Cell Lung Cancer, Small Cell Lung Cancer, Rovalpituzumab tesirine, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Rovalpituzumab tesirine
Arm Type
Experimental
Arm Description
Part A Dose Escalation: Rovalpituzumab tesirine intravenous (IV) (various doses and dose regimens) on Day 1 of each 6-week cycle
Arm Title
Part B: Rovalpituzumab tesirine
Arm Type
Experimental
Arm Description
Part B Dose Expansion: Rovalpituzumab tesirine dosed at regimen(s) previously demonstrated in Part A to not to exceed the maximum tolerated dose (MTD).
Intervention Type
Drug
Intervention Name(s)
Rovalpituzumab tesirine
Intervention Description
Intravenous
Primary Outcome Measure Information:
Title
Number of participants with dose-limiting toxicities (DLT)
Description
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame
Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
Secondary Outcome Measure Information:
Title
Duration of response (DOR)
Description
DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
Time Frame
First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
Title
Overall survival (OS)
Description
OS is defined as the time from the date of first dose to the date of death.
Time Frame
First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
Title
Progression-free survival (PFS)
Description
PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.
Time Frame
First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
Title
Clinical benefit rate (CBR)
Description
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.
Time Frame
First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Ctr Hosp East /ID# 161432
City
Kashiwa-shi
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Kyushu University Hospital /ID# 161430
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kinki University -Osakasayama Campus /ID# 161431
City
Osakasayama-shi
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
National Cancer Center Hospital /ID# 161429
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Wakayama Medical University /ID# 161428
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31446987
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.
Results Reference
background
PubMed Identifier
29290251
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.
Results Reference
derived

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

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