- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086239
A Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
July 28, 2021 updated by: AbbVie
An Open-Label Study on the Safety and Tolerability of Rovalpituzumab Tesirine in Japanese Patients With Advanced, Recurrent Small Cell Lung Cancer
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Wakayama, Japan, 641-8510
- Wakayama Medical University /ID# 161428
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Ctr Hosp East /ID# 161432
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Fukuoka
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Fukuoka-shi, Fukuoka, Japan, 812-8582
- Kyushu University Hospital /ID# 161430
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Osaka
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Osakasayama-shi, Osaka, Japan, 589-8511
- Kinki University -Osakasayama Campus /ID# 161431
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Tokyo
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Chuo-ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital /ID# 161429
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
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Intravenous
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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).
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Intravenous
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with dose-limiting toxicities (DLT)
Time Frame: Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
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DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
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Up to 3 weeks after the initial dose of study drug (first 3 weeks of Cycle 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DOR)
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.
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DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Objective Response Rate (ORR)
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.
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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.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Overall survival (OS)
Time Frame: First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
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OS is defined as the time from the date of first dose to the date of death.
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First dose of study drug through long-term follow up; Up to 24 months after participant's first dose.
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Progression-free survival (PFS)
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.
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PFS time is defined as the time from the first dose of study drug to progression or death, whichever occurs first.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Clinical benefit rate (CBR)
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.
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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.
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First dose of study drug through at least 42 days after last dose; Up to a minimum 18 weeks after participant's first dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 28, 2017
Primary Completion (Actual)
January 30, 2018
Study Completion (Actual)
August 20, 2018
Study Registration Dates
First Submitted
March 17, 2017
First Submitted That Met QC Criteria
March 17, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCRX001-008
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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