Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2016-003503-64-DE |
Date of registration:
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26/04/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU)
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects with Extensive Stage Small Cell Lung Cancer (MERU) |
Date of first enrolment:
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06/07/2017 |
Target sample size:
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740 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-003503-64 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belarus
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Belgium
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Brazil
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Bulgaria
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Canada
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China
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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Germany
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Greece
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Hong Kong
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Hungary
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Ireland
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Israel
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Japan
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Netherlands
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Norway
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Poland
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Portugal
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Russian Federation
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Serbia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Name:
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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Histologically or cytologically confirmed ED SCLC (extensive stage disease at initial diagnosis) with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR] per RECIST v.1.1) following completion of 4 cycles of first-line platinum-based therapy • Subject is eligible to be randomized at least 3 but no more than 9 weeks from Day 1 of the fourth cycle of first-line platinum-based chemotherapy. • Participants with a history of central nervous system (CNS) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved CNS disease status • Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 • Participants must have adequate bone marrow, renal and hepatic function
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria: • Any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria 3-5 for SCLC. • Any disease-directed radiotherapy (except PCI, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for CNS metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy. • Prior exposure to a pyrrolobenzodiazepine (PBD)- or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Extensive Stage Small Cell Lung Cancer (ED SCLC)
MedDRA version: 20.0
Level: PT
Classification code 10041068
Term: Small cell lung cancer extensive stage
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Rovalpituzumab tesirine Product Code: (SC16LD6.5) Pharmaceutical Form: Solution for infusion INN or Proposed INN: ROVALPITUZUMAB TESIRINE CAS Number: 1613313-09-9 Current Sponsor code: SC16LD6.5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Product Name: dexamethasone Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE Current Sponsor code: DEXAMETHASONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 8- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: PFS - From randomization to disease progression, or death of any cause, whichever occurs first. OS - From randomization to death of any cause
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Secondary Objective: To evaluate if rovalpituzumab tesirine improves progression-free survival by CRAC and overall survival in all randomized subjects compared to placebo. To assess change in patient reported outcomes (PRO) with physical functioning as measured by the EORTC QLQ-C30 questionnaire in all randomized subjects compared to placebo.
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Main Objective: To evaluate if rovalpituzumab tesirine improves progression-free survival, assessed by a Central Radiographic Assessment Committee (CRAC) according to RECIST v1.1, and overall survival in subjects with extensive-stage small cell lung cancer (EDSCLC) tumors with a high level of DLL3 expression (DLL3high) who have ongoing clinical benefit (SD, PR, or CR) following the completion of 4 cycles of first-line, platinum-based chemotherapy (cisplatin or carboplatin plus irinotecan or etoposide) compared to placebo.
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Primary end point(s): Progression-free survival (PFS) and overall survival (OS) in subjects with DLL3 high ED SCLC are the two primary efficacy endpoints.
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Secondary Outcome(s)
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Secondary end point(s): - OS - PFS per the CRAC based on RECIST v1.1 - EORTC QLQ-C30 physical functining domain. - Objective response rate (ORR) per the CRAC and investigator assessment, respectively - Clinical benefit rate (CBR) per the CRAC and investigator assessment, respectively - Duration of response (DOR) per the CRAC and investigator assessment, respectively Response assessment will be based on RECIST v1.1. - Change from baseline in all PRO domains (except physical functioning) measurd by EORTC QLQ-C30 / LC13 and EQ-5D-5L. - Safety endpoints will be summarized using data from the Safety set.
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Timepoint(s) of evaluation of this end point: Disease progression will be defined as radiographic progression of disease by RECIST version 1.1. PFS, ORR, CBR, DOR - From randomization to disease progression, or death of any cause, whichever occurs first. Changes in PROs - From baseline (the assessment prior to first dose) to disease progression, or death of any cause, whichever occurs first. Safety endpoints - From baseline to specified time points throughout the study.
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Secondary ID(s)
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M16-298
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2016-003503-64-EE
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NCT03033511
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Source(s) of Monetary Support
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AbbVie Inc
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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