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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1 February 2020 |
Main ID: |
EUCTR2013-005020-42-FI |
Date of registration:
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26/03/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
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Scientific title:
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Randomized, Double-Blind, Multicenter, Phase 3 Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) |
Date of first enrolment:
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22/04/2014 |
Target sample size:
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975 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005020-42 |
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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Brazil
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Canada
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Croatia
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Czech Republic
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Denmark
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Egypt
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Ireland
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Israel
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Italy
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Latvia
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Lithuania
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Mexico
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Netherlands
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New Zealand
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Norway
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Poland
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Portugal
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Puerto Rico
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Russian Federation
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Serbia
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Slovakia
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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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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
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+44 1628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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Abbvie Limited |
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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
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+44 1628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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Abbvie Limited |
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Key inclusion & exclusion criteria
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Inclusion criteria: -Subject must be = 18 years of age.
-Life expectancy > 12 weeks
-Subject must have cytologically or histologically confirmed squamous NSCLC.
-Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
-Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1). 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 325 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 650
Exclusion criteria: -Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
-Subject has a known hypersensitivity to platinum compounds. Subject has peripheral neuropathy = grade 2.
-Subject has non-squamous NSCLC, or a known EGFR mutation of exon 19 deletion or L858R mutation in exon 21, or a known ALK gene rearrangement.
-Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced or Metastatic Squamous Non-Small-Cell Lung Cancer (NSCLC)
MedDRA version: 18.1
Level: LLT
Classification code 10025044
Term: Lung cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Veliparib 40 mg Product Code: ABT-888 Pharmaceutical Form: Capsule INN or Proposed INN: Veliparib Current Sponsor code: ABT-888 Other descriptive name: VELIPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Capsule 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: Time to death for a given subject will be defined as the number of days from the date that the subject was randomized to the date of the subject's death.
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Main Objective: The primary objective of the study is to assess whether the addition of oral veliparib to carboplatin and paclitaxel will improve overall survival (OS) in current smokers when compared to the addition of placebo to carboplatin and paclitaxel, in subjects with previously untreated locally advanced and metastatic squamous NSCLC
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Primary end point(s): Overall Survival (OS) in current smokers.
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Secondary Objective: The secondary objectives of the study are to assess the effects of veliparib combination therapy on OS in all subjects, progression-free survival (PFS) and objective response rate (ORR) in current smokers and in all subjects.
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: OS: see E.5.1.1.
PFS will be defined as the number of days from the date of randomization to the date of disease progression or death if disease progression is not reached.
ORR is defined as the proportion of subjects with complete or partial response as determined by the investigator per RECIST (version 1.1).
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Secondary end point(s): OS in whole population, Progression-free Survival (PFS); Objective Response Rate (ORR).
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Secondary ID(s)
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2013-005020-42-SK
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M11-089
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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: 15/04/2014
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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