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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5 April 2021 |
Main ID: |
EUCTR2014-000345-70-HU |
Date of registration:
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03/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without ABT-888 in Metastatic or Locally Advanced Unresectable Breast Cancer
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Scientific title:
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A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer |
Date of first enrolment:
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26/08/2014 |
Target sample size:
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500 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000345-70 |
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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Argentina
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Australia
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Austria
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Belarus
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Belgium
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Canada
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Chile
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Colombia
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Czech Republic
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Czechia
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Denmark
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Estonia
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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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Italy
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Japan
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Korea, Democratic People's 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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Puerto Rico
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Romania
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Russian Federation
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Singapore
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South Africa
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Spain
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Sweden
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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
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: -Men and women = 18 years of age; - Histologically or cytologically confirmed breast cancer that is either locally advanced or metastatic; - Locally advanced breast cancer must not be amenable to surgical resection or radiation with curative intent; - Suspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation; Measurable or non-measurable (but radiologically evaluable) disease per RECIST version 1.1 on computed tomography (CT) scan. 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 335 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria: - Received anticancer agent(s) or an investigational agent within 21days prior to C1D-2 or radiotherapy within 28 days prior to C1D-2; - More than 2 prior lines of cytotoxic chemotherapy (e.g., gemcitabine, doxorubicin, capecitabine) for metastatic disease; - More than one prior line of platinum therapy for breast cancer; - Subjects who have progressed or recurred within 12 months of completing platinum therapy or received > 1 prior line of platinum therapy for breast cancer in any setting (adjuvant or neoadjuvant) will be excluded; - Prior therapy with PARP inhibitors - Prior taxane therapy administered for the treatment of metastatic breast cancer with exceptions (see protocol); - Subjects with active brain metastases or leptomeningeal disease.
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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HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated mutation (BRCA1 and BRCA2) Breast Cancer
MedDRA version: 20.0
Level: LLT
Classification code 10027475
Term: Metastatic breast cancer
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: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide 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
Product Name: Veliparib 50 mg Product Code: ABT-888 Pharmaceutical Form: Capsule INN or Proposed INN: Veliparib Current Sponsor code: ABT-888 Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Product Name: Veliparib 100 mg Product Code: ABT-888 Pharmaceutical Form: Capsule INN or Proposed INN: Veliparib Current Sponsor code: ABT-888 Other descriptive name: 2-((R)-2-methylpyrrolidin-2-yl)-1H-benzimidazole-4-carboxamide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
Trade Name: Paclitaxel Product Name: 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-
Trade Name: Carboplatin Product Name: Carboplatin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CARBOPLATIN CAS Number: 41575-94-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
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Primary Outcome(s)
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Secondary Objective: The secondary objectives of the study are to assess overall survival (OS), clinical benefit rate (CBR), objective response rate (ORR), Progression Free Survival 2 (PFS2) and duration of overall response (DOR) in subjects treated with veliparib in combination with C/P versus subjects treated with placebo with C/P.
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Timepoint(s) of evaluation of this end point: Progression-free Survival (PFS): will be evaluated according to radiographic progression per RECIST (version 1.1) and survival information (death). Radiologic tumor response and disease progression will be assessed by CT scan utilizing RECIST (version 1.1). Assessments were be performed at Screening, at 9-week intervals thereafter, and at the Final Visit, if not performed within the last 4 weeks. Following the primary analysis and implementation of Protocol Amendment 4 the tumor assessment interval may be increased to every 12 weeks from lastscan until tumor progression; at investigator discretion, the interval between scans may be longer than 12 weeks but must not exceed 24 weeks.
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Main Objective: The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and in Her-2 Negative Metastatic or Locally Advanced Unresectable Breast Cancer
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Primary end point(s): Progression Free Survival
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: CBR, ORR & DOR evaluated according to radiographic progression per RECIST (v1.1). Assessments performed at Screening, at 9wks intervals thereafter & at the Final Visit. Following primary analysis & implementation of PA4, the tumor assessment interval may increased to every 12wks from last scan until tumor progression, the interval between scans may be longer than 12wks but must not exceed 24wks.Overall Survival (OS): will be evaluated according to survival information & post treatment information collected every 2mnths beginning on date the subject is registered off study & until the endpointof death, the subject is lost to follow-up or until the study termination by AbbVie. PFS2: will be evaluated according to survival information & post treatment info collected every 2 mnths.
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Secondary end point(s): Clinical benefit rate (CBR) Objective Response Rate (ORR) Duration of Overall Response (DOR) Overall Survival (OS) PFS2
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Secondary ID(s)
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2014-000345-70-FI
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M12-914
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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: 18/08/2014
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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