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
NCT ID: NCT01506609
Last Updated: 2021-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
294 participants
INTERVENTIONAL
2012-01-23
2020-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Veliparib
Temozolomide
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.
Placebo
Carboplatin
Paclitaxel
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.
Veliparib
Carboplatin
Paclitaxel
Interventions
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Placebo
Veliparib
Carboplatin
Temozolomide
Paclitaxel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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University of Alabama at Birmingham - Main /ID# 62994
Birmingham, Alabama, United States
Banner MD Anderson Cancer Ctr /ID# 118695
Gilbert, Arizona, United States
University of Arkansas for Medical Sciences /ID# 60750
Little Rock, Arkansas, United States
Moore UC San Diego Cancer Center /ID# 60754
La Jolla, California, United States
The Angeles Clinic and Researc /ID# 60743
Los Angeles, California, United States
Stanford University School of Med /ID# 65488
Stanford, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 60760
West Hollywood, California, United States
Univ of Colorado Cancer Center /ID# 60751
Aurora, Colorado, United States
Lynn Cancer Institute, Boca /ID# 60749
Boca Raton, Florida, United States
Holy Cross Hospital /ID# 62995
Fort Lauderdale, Florida, United States
Moffitt Cancer Center /ID# 60746
Tampa, Florida, United States
Florida Cancer Specialists - East /ID# 60762
West Palm Beach, Florida, United States
University of Illinois - Chicago /ID# 106175
Chicago, Illinois, United States
Northwestern University Feinberg School of Medicine /ID# 60755
Chicago, Illinois, United States
Rush University Medical Center /ID# 65489
Chicago, Illinois, United States
Midwestern Regional CTC /ID# 60744
Zion, Illinois, United States
Johns Hopkins University /ID# 60759
Baltimore, Maryland, United States
Massachusetts General Hospital /ID# 64582
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 93833
Boston, Massachusetts, United States
William Beaumont Hospital /ID# 95417
Royal Oak, Michigan, United States
Washington University-School of Medicine /ID# 62724
St Louis, Missouri, United States
Beth Israel Medical Center /ID# 87993
New York, New York, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 63222
New York, New York, United States
Duke University Medical Center /ID# 60747
Durham, North Carolina, United States
Penn State University and Milton S. Hershey Medical Center /ID# 62723
Hershey, Pennsylvania, United States
University of Pennsylvania /ID# 60753
Philadelphia, Pennsylvania, United States
University of Pittsburgh MC /ID# 60758
Pittsburgh, Pennsylvania, United States
University of Pittsburgh MC /ID# 65486
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina /ID# 60752
Charleston, South Carolina, United States
The West Clinic /ID# 65487
Memphis, Tennessee, United States
The West Clinic /ID# 94599
Memphis, Tennessee, United States
The West Clinic /ID# 94600
Memphis, Tennessee, United States
UT Southwestern Medical Center /ID# 60745
Dallas, Texas, United States
Houston Methodist Hospital - Scurlock Tower /ID# 60742
Houston, Texas, United States
Coiba /Id# 65219
Berazategui, Buenos Aires, , Argentina
ISIS Centro Especializado /ID# 65226
Santa Fe, , Argentina
The Prince of Wales Hospital /ID# 63271
Randwick, New South Wales, Australia
Southern Medical Day Care Ctr /ID# 63274
Wollongong, New South Wales, Australia
Mater Misericordiae Limited /ID# 63276
South Brisbane, Queensland, Australia
Royal Adelaide Hospital /ID# 63280
Adelaide, South Australia, Australia
Royal Hobart Hospital /ID# 63279
Hobart, Tasmania, Australia
Peter MacCallum Cancer Ctr /ID# 63272
Melbourne, Victoria, Australia
Royal Melbourne Hospital /ID# 63278
Parkville, Victoria, Australia
Mount Hospital /ID# 65262
Perth, Western Australia, Australia
Cliniques Universitaires Saint Luc /ID# 96135
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Grand Hôpital de Charleroi /ID# 96136
Charleroi, Hainaut, Belgium
AZ St-Jan Brugge-Oostende AV /ID# 107315
Bruges, West-Vlaanderen, Belgium
UZ Antwerp /ID# 96945
Edegem, , Belgium
UZ Leuven /ID# 96138
Leuven, , Belgium
CHU UCL Namur /ID# 110595
Namur, , Belgium
Hospital Bruno Born / Sociedade Beneficencia e Caridade de Lajeado /ID# 65247
Lajeado, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de /ID# 65244
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre /ID# 65242
Porto Alegre, Rio Grande do Sul, Brazil
Sunnybrook Health Sciences Ctr /ID# 77373
Toronto, Ontario, Canada
CHUM - Notre-Dame Hospital /ID# 67862
Montreal, Quebec, Canada
Jewish General Hospital /ID# 69893
Montreal, Quebec, Canada
CHUQ-Hospital St. Sacrement /ID# 68902
Québec, Quebec, Canada
Masarykuv onkologicky ustav /ID# 65170
Brno, , Czechia
Palacky University /ID# 63923
Olomouc, , Czechia
Vseobecna Fakultni Nemocnice /ID# 65172
Prague, , Czechia
Vejle Sygehus /ID# 65173
Vejle, Region Syddanmark, Denmark
Rigshospitalet, Finsen Centre /ID# 67822
Copenhagen, , Denmark
Docrates Cancer Center /ID# 63924
Helsinki, , Finland
Tampere University Hospital /ID# 102417
Tampere, , Finland
Hopital Universitaire Purpan /ID# 98815
Toulouse, Haute-Garonne, France
Institut de Cancer de l'Ouest /ID# 63927
Saint-Herblain, Loire-Atlantique, France
Centre Leon Berard /ID# 106675
Lyon, Rhone, France
Pays-Basque Ctr Oncology/Radio /ID# 65176
Bayonne, , France
Institut Paoli-Calmettes /ID# 65175
Marseille, , France
Hopital Rene Huguenin /ID# 65177
Saint-Cloud, , France
Centre Paul Strauss /ID# 100275
Strasbourg, , France
Institut Curie /ID# 63926
Paris, Île-de-France Region, France
Bajcsy-Zsilinszky Korhaz /ID# 65179
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 65178
Debrecen, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928
Szolnok, , Hungary
Rabin Medical Center /ID# 63929
Petakh Tikva, Tel Aviv, Israel
Soroka University Medical Center /ID# 65180
Beersheba, , Israel
Assaf Harofeh Medical Center /ID# 65181
Be’er Ya‘aqov, , Israel
Rambam Health Care Campus /ID# 63930
Haifa, , Israel
Shaare Zedek Medical Center /ID# 116575
Jerusalem, , Israel
Gastroenterology Institute, Division of Medicine /ID# 63931
Jerusalem, , Israel
Sheba Medical Center /ID# 63932
Ramat Gan, , Israel
Kaplan Medical Center /ID# 63933
Rehovot, , Israel
Erasmus Medisch Centrum /ID# 96275
Rotterdam, , Netherlands
Haukeland University Hospital /ID# 67982
Bergen, Hordaland, Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975
Rzeszów, Podkarpackie Voivodeship, Poland
Centrum Onkologii Lukaszczyka /ID# 73393
Bydgoszcz, , Poland
Olsztynski Osrodek Onkologi /ID# 71060
Olsztyn, , Poland
NZOZ Centrum Medyczne HCP /ID# 68102
Poznan, , Poland
Wielkopolskie Centrum Onkologi /ID# 71061
Poznan, , Poland
S.C. lanuli Med Consult SRL /ID# 106955
Bucharest, , Romania
lnstitutul Oncologic Trestiore /ID# 96742
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta /ID# 96741
Cluj-Napoca, , Romania
Inst Oncology Prof. Chiricuta /ID# 96740
Cluj-Napoca, , Romania
Sc Oncolab Srl /Id# 96745
Craiova, , Romania
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 65263
Moscow, Moscow, Russia
Chelyabinsk Reg Clin Oncology /ID# 63938
Chelyabinsk, , Russia
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 102415
Murmansk, , Russia
City Clinical Hospital 1 /ID# 102416
Novosibirsk, , Russia
Pyatigorsk Oncology Dispensary /ID# 65264
Pyatigorsk, , Russia
Birch A Healthcare /ID# 65265
Saint Petersburg, , Russia
N.N. Petrov Research Inst Onc /ID# 65269
Saint Petersburg, , Russia
N.N. Petrov Research Inst Onc /ID# 78973
Saint Petersburg, , Russia
Volgograd Reg Onc Disp #3 /ID# 98035
Volzhsky, , Russia
Hospital Universitario Vall d'Hebron /ID# 97415
Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 97418
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 97417
Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 97416
Madrid, , Spain
Hospital Universitario Virgen de la Victoria /ID# 97976
Málaga, , Spain
Hospital Clinico Universitario de Valencia /ID# 97975
Valencia, , Spain
Skanes Universitetssjukhus /ID# 96475
Malmo, Skåne County, Sweden
Sahlgrenska University Hosp /ID# 97715
Gothenburg, , Sweden
Karolinska Univ Sjukhuset /ID# 98037
Solna, , Sweden
Cherkassy Regional Onc Ctr /ID# 97698
Cherkasy, , Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 63940
Dnipro, , Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 97696
Kharkiv, , Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 63941
Lviv, , Ukraine
Odessa National Medical Univ /ID# 65278
Odesa, , Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 97697
Poltava, , Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 65280
Sumy, , Ukraine
Countries
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References
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Han HS, Dieras V, Robson M, Palacova M, Marcom PK, Jager A, Bondarenko I, Citrin D, Campone M, Telli ML, Domchek SM, Friedlander M, Kaufman B, Garber JE, Shparyk Y, Chmielowska E, Jakobsen EH, Kaklamani V, Gradishar W, Ratajczak CK, Nickner C, Qin Q, Qian J, Shepherd SP, Isakoff SJ, Puhalla S. Veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in patients with BRCA1/2 locally recurrent/metastatic breast cancer: randomized phase II study. Ann Oncol. 2018 Jan 1;29(1):154-161. doi: 10.1093/annonc/mdx505.
Isakoff SJ, Puhalla S, Domchek SM, Friedlander M, Kaufman B, Robson M, Telli ML, Dieras V, Han HS, Garber JE, Johnson EF, Maag D, Qin Q, Giranda VL, Shepherd SP. A randomized Phase II study of veliparib with temozolomide or carboplatin/paclitaxel versus placebo with carboplatin/paclitaxel in BRCA1/2 metastatic breast cancer: design and rationale. Future Oncol. 2017 Feb;13(4):307-320. doi: 10.2217/fon-2016-0412. Epub 2016 Oct 14.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-002913-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M12-895
Identifier Type: -
Identifier Source: org_study_id