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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13 July 2020 |
Main ID: |
EUCTR2014-002565-30-GB |
Date of registration:
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11/03/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Randomized, Open-Label, Multicenter Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer Who Are Current or Former Smokers.
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Scientific title:
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A Randomized, Open-Label, Multicenter, Phase 3 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers |
Date of first enrolment:
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01/12/2014 |
Target sample size:
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595 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002565-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
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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Argentina
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Australia
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Canada
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Czech Republic
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Denmark
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Egypt
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Finland
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France
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Germany
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Hungary
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Israel
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Japan
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Korea, Republic of
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Netherlands
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New Zealand
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Russian Federation
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South Africa
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Spain
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Taiwan
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Turkey
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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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+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
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: - Subject must be = 18 years of age. Life expectancy > 12 weeks.
- Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
- Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
- Subject must have at least 1 unidimensional measurable NSCLC lesion on a CT scan as defined by RECIST (version 1.1).
- Subject must consent to provide archived tissue or cytology sample of NSCLC lesion (primary or metastatic) for analysis if available. 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 286 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 309
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 squamous NSCLC, or an untreated 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 or chemoradiotherapy for NSCLC.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Advanced or Metastatic Non-squamous Non Small Cell Lung Cancer (NSCLC) MedDRA version: 20.0
Level: LLT
Classification code 10029514
Term: Non-small cell lung cancer NOS
System Organ Class: 100000004864
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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 (ABT-888) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40-
Product Name: Carboplatin Product Code: Carboplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575-94-4 Other descriptive name: CARBOPLATIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Product Name: Paclitaxel Product Code: Paclitaxel Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: PACLITAXEL CAS Number: 33069-62-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of the study are to assess if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in the entire study population; to compare progression-free survival (PFS) and to compare objective response rate (ORR) between the two treatment arms in LSP positive subjects or in entire study population.
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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 if treatment with veliparib plus carboplatin and paclitaxel results in improved survival compared to Investigator's choice of standard chemotherapy in Lung Subtype Panel (LSP) positive subjects with metastatic or advanced NSCLC.
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Primary end point(s): Overall Survival (OS) in LSP+ subgroup.
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Secondary Outcome(s)
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Secondary end point(s): Progression Free Survival (PFS) in LSP+ subgroup, Objective Response
Rate (ORR) in LSP+ subgroup, OS in all subjects, PFS in all subjects,ORR
in all subjects.
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Timepoint(s) of evaluation of this end point: PFS will be defined as the number of days from the date that the subject was randomized to the date the subject experiences an event of disease progression or to the date of death (all causes of mortality) if disease progression is not reached. ORR is defined as the proportion of subjects with complete or partial response using measurements according to RECIST (version 1.1).
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Secondary ID(s)
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2014-002565-30-FI
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M14-359
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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: 01/12/2014
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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