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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01506609




Registration number
NCT01506609
Ethics application status
Date submitted
6/01/2012
Date registered
10/01/2012

Titles & IDs
Public title
Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide (TMZ) or In Combination With Carboplatin and Paclitaxel Versus Placebo in Participants With Breast Cancer Gene (BRCA)1 and BRCA2 Mutation and Metastatic Breast Cancer
Scientific title
A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination With Temozolomide or Veliparib in Combination With Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects With BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
Secondary ID [1] 0 0
2011-002913-12
Secondary ID [2] 0 0
M12-895
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Experimental: Veliparib with Temozolomide - Veliparib 40 mg twice daily (BID) Days 1 through 7 plus TMZ 150 to 200 mg/m\^2 QD Days 1 through 5 in each 28-day cycle.

Placebo comparator: Placebo with Carboplatin and Paclitaxel - Placebo BID Days 1 through 7 plus carboplatin target area under the curve (mg•min/mL) (AUC) 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.

Experimental: Veliparib with Carboplatin and Paclitaxel - Veliparib 80 mg BID Days 1 through 7 plus carboplatin target AUC 6 administered on Day 3 of each 21-day cycle and paclitaxel 175 mg/m\^2 administered on Day 3 of each 21-day cycle.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for PFS was 34 months.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From Cycle 1 Day 1 until participant's death or 3 years post discontinuation (data cutoff date: 04 March 2016); maximum duration of follow up for OS was 72 months.
Secondary outcome [2] 0 0
Clinical Benefit Rate (CBR) at Week 18
Timepoint [2] 0 0
Week 18
Secondary outcome [3] 0 0
Objective Response Rate (ORR)
Timepoint [3] 0 0
Radiographic evaluation every 9 weeks, clinical evaluation every cycle (data cutoff date: 04 March 2016); maximum duration of follow up for ORR was 34 months.
Secondary outcome [4] 0 0
Change From Baseline at Week 18 in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) Sensory Subscale Score
Timepoint [4] 0 0
Baseline, Week 18

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed breast cancer that is either locally recurrent or metastatic.
* Locally recurrent disease must not be amenable to surgical resection or radiation with curative intent.
* Must have a documented deleterious Breast Cancer Gene BRCA1 or BRCA2 germline mutation.
* If Human Epidermal Growth Factor Receptor (HER2) positive, subjects must have received and progressed on at least one prior standard HER2 directed therapy or the subject must be ineligible to receive anti-HER2 therapy.
* Measurable or non-measurable (but radiologically evaluable) disease by RECIST (Response Evaluation Criteria in Solid Tumors) criteria 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
* Subject must have adequate bone marrow, renal and hepatic function.
* Subject must not be pregnant or plan to conceive a child.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Received anticancer agent(s) or an investigational agent within 21 days prior to C1D1, or radiotherapy within 28 days prior Cycle 1 Day 1.
* More than 2 prior lines of cytotoxic chemotherapy.
* Prior treatment of breast cancer with temozolomide, a platinum agent, or a Poly (ADP ribose) Polymerase (PARP) inhibitor.
* Prior taxane therapy for metastatic breast cancer.
* A history of or evidence of brain metastases or leptomeningeal disease.
* A history of uncontrolled seizure disorder.
* Pre-existing neuropathy from any cause in excess of Grade 1.
* Known history of allergic reaction to cremophor/paclitaxel.
* Clinical significant uncontrolled conditions, active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
* Pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/09/2020
Sample size
Target
Accrual to date
Final
294
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
The Prince of Wales Hospital /ID# 63271 - Randwick
Recruitment hospital [2] 0 0
Southern Medical Day Care Ctr /ID# 63274 - Wollongong
Recruitment hospital [3] 0 0
Mater Misericordiae Limited /ID# 63276 - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 63280 - Adelaide
Recruitment hospital [5] 0 0
Royal Hobart Hospital /ID# 63279 - Hobart
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Ctr /ID# 63272 - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital /ID# 63278 - Parkville
Recruitment hospital [8] 0 0
Mount Hospital /ID# 65262 - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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Florida
Country [7] 0 0
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Illinois
Country [8] 0 0
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Maryland
Country [9] 0 0
United States of America
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Massachusetts
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Michigan
Country [11] 0 0
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Missouri
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New York
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North Carolina
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Pennsylvania
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South Carolina
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United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Argentina
State/province [18] 0 0
Berazategui, Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Santa Fe
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Belgium
State/province [20] 0 0
Bruxelles-Capitale
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Belgium
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Hainaut
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Belgium
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West-Vlaanderen
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Belgium
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Edegem
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Belgium
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Leuven
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Belgium
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Namur
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Brazil
State/province [26] 0 0
Rio Grande Do Sul
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Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
Czechia
State/province [29] 0 0
Brno
Country [30] 0 0
Czechia
State/province [30] 0 0
Olomouc
Country [31] 0 0
Czechia
State/province [31] 0 0
Prague
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Denmark
State/province [32] 0 0
Syddanmark
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Denmark
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Copenhagen
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Finland
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Helsinki
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Finland
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Tampere
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France
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Haute-Garonne
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France
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Ile-de-France
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France
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Loire-Atlantique
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France
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Rhone
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France
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Bayonne
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France
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Marseille
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France
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Saint-cloud
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France
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Strasbourg
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
State/province [46] 0 0
Szolnok
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Israel
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Tel-Aviv
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Israel
State/province [48] 0 0
Be'er Sheva
Country [49] 0 0
Israel
State/province [49] 0 0
Be'er Ya'akov
Country [50] 0 0
Israel
State/province [50] 0 0
Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Rehovot
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Netherlands
State/province [54] 0 0
Rotterdam
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Norway
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Hordaland
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Poland
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Podkarpackie
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Poland
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Bydgoszcz
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Poland
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Olsztyn
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Poland
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Poznan
Country [60] 0 0
Romania
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Bucharest
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Romania
State/province [61] 0 0
Cluj
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Romania
State/province [62] 0 0
Craiova
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Moskva
Country [64] 0 0
Russian Federation
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Chelyabinsk
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Russian Federation
State/province [65] 0 0
Murmansk
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Novosibirsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Pyatigorsk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
Country [69] 0 0
Russian Federation
State/province [69] 0 0
Volzhsky
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Madrid
Country [72] 0 0
Spain
State/province [72] 0 0
Malaga
Country [73] 0 0
Spain
State/province [73] 0 0
Valencia
Country [74] 0 0
Sweden
State/province [74] 0 0
Skane Lan
Country [75] 0 0
Sweden
State/province [75] 0 0
Goteborg
Country [76] 0 0
Sweden
State/province [76] 0 0
Solna
Country [77] 0 0
Ukraine
State/province [77] 0 0
Cherkasy
Country [78] 0 0
Ukraine
State/province [78] 0 0
Dnipro
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kharkiv
Country [80] 0 0
Ukraine
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Lviv
Country [81] 0 0
Ukraine
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Odesa
Country [82] 0 0
Ukraine
State/province [82] 0 0
Poltava
Country [83] 0 0
Ukraine
State/province [83] 0 0
Sumy

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01506609