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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03086239
Recruitment Status : Completed
First Posted : March 22, 2017
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : April 28, 2017
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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) ]
    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) [ 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. ]
    DOR is defined as the time from the initial objective response to disease progression or death, whichever occurs first.

  2. 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. ]
    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) [ Time Frame: 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) [ 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. ]
    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) [ 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. ]
    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
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086239


Locations
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Japan
National Cancer Ctr Hosp East /ID# 161432
Kashiwa-shi, Chiba, Japan, 277-8577
Kyushu University Hospital /ID# 161430
Fukuoka-shi, Fukuoka, Japan, 812-8582
Kinki University -Osakasayama Campus /ID# 161431
Osakasayama-shi, Osaka, Japan, 589-8511
National Cancer Center Hospital /ID# 161429
Chuo-ku, Tokyo, Japan, 104-0045
Wakayama Medical University /ID# 161428
Wakayama, Japan, 641-8510
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03086239    
Other Study ID Numbers: SCRX001-008
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms