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The Study Evaluating Efficacy And Tolerability Of Veliparib in Combination With Temozolomide or In Combination With Carboplatin and Paclitaxel Versus Placebo in Subjects With BRCA1 and BRCA2 Mutation and Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01506609
First received: January 6, 2012
Last updated: July 14, 2017
Last verified: July 2017
  Purpose
The Study Evaluating Efficacy And Tolerability of Veliparib in Combination with Temozolomide or Veliparib/Placebo in Combination with Carboplatin and Paclitaxel in Subjects with locally recurrent Breast Cancer not amenable to therapy with curative intent, or metastatic breast cancer and a documented (BRCA1) and (BRCA2) deleterious germline mutation.

Condition Intervention Phase
Metastatic Breast Cancer Drug: Veliparib Drug: Temozolomide Drug: Carboplatin Drug: Paclitaxel Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Progression -Free Survival [ Time Frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]
  • Clinical Benefit Rate (CBR) [ Time Frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation ]
  • Objective Response Rate [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ]

Other Outcome Measures:
  • Chemotherapy-Induced Peripheral Neuropathy (CIPN) [ Time Frame: From Cycle 1 Day 1 for subjects on the carboplatin and paclitaxel treatment arm, through 30 Day Follow-up Visit. ]
    CIPN (as assessed by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy


Estimated Enrollment: 290
Study Start Date: January 24, 2012
Estimated Study Completion Date: August 31, 2017
Primary Completion Date: May 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veliparib with Temozolomide
Veliparib on Day 1 thru 7 and temozolomide on Day 1 thru 5 of a 28-day cycle.
Drug: Veliparib
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
Other Name: ABT-888
Drug: Temozolomide
Days 1 through 5 of 28-day cycle (in combination with veliparib).
Other Name: Temodal
Experimental: Veliparib with Carboplatin and Paclitaxel
Veliparib on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
Drug: Veliparib
Days 1 through 7 of 28-day cycle (in combination with Temozolomide) or Days 1 through 7 of 21-day cycle (in combination with Carboplatin and Paclitaxel).
Other Name: ABT-888
Drug: Carboplatin
Day 3 of 21-day cycle
Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol
Placebo Comparator: Placebo with Carboplatin and Paclitaxel
Placebo on Day 1 thru 7 and carboplatin/paclitaxel on Day 3 of a 21-day cycle.
Drug: Carboplatin
Day 3 of 21-day cycle
Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol
Drug: Placebo
Placebo comparator for Veliparib days 1 through 7 of 21-day cycle (in combination with carboplatin and/or paclitaxel).

Detailed Description:
Subjects will be randomized in a 1:1:1 ratio to one of the three treatment groups. The safety of each treatment group will be assessed by evaluating study drug exposure, adverse events, serious adverse events, all deaths, changes in laboratory determinations, and vital sign parameters. The Clinical Benefit Rate (CBR) and Objective Response Rate (ORR) as well as Progression-free survival (PFS) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 will be assessed. Study visits will be conducted according to the protocol schedule and randomization group. Study visits will include physical examination, laboratory blood sample collection, and assessment of vital signs, medical history and urinalysis. 12-lead Electrocardiogram (ECG) will be performed at protocol specified visits.
  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 â€" active infection, myocardial infarction, stroke, or transient ischemic attack, psychiatric illness/social situations that would limit compliance.
  • Pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506609

  Hide Study Locations
Locations
United States, Alabama
University of Alabama-Birmingham /ID# 62994
Birmingham, Alabama, United States, 35249-3300
United States, Arizona
Banner MD Anderson Cancer Center /ID# 118695
Gilbert, Arizona, United States, 85234
United States, Arkansas
University of Arkansas for Medical Sciences /ID# 60750
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Health System /ID# 60754
La Jolla, California, United States, 92093
The Angeles Clinic and Research Institute /ID# 60743
Los Angeles, California, United States, 90025
The Angeles Clinic and Research Institute /ID# 93813
Los Angeles, California, United States, 90025
Cedars-Sinai Medical Center /ID# 60760
Los Angeles, California, United States, 90048
Cedars-Sinai Medical Center /ID# 96549
Los Angeles, California, United States, 90048
Stanford University School of Medicine /ID# 65488
Stanford, California, United States, 94305-5826
United States, Colorado
University of Colorado Denver and the Health Sciences /ID# 60751
Aurora, Colorado, United States, 80045
United States, Florida
Lynn Cancer Institute, Boca Ration Regional Hospital /ID# 60749
Boca Raton, Florida, United States, 33486
Holy Cross Hospital /ID# 62995
Fort Lauderdale, Florida, United States, 33308
Moffitt Cancer Center and Research Institute /ID# 60746
Tampa, Florida, United States, 33612
Florida Cancer Specialists /ID# 60762
West Palm Beach, Florida, United States, 33401
United States, Illinois
Northwestern University /ID# 60755
Chicago, Illinois, United States, 60611
Rush University Medical Center /ID# 65489
Chicago, Illinois, United States, 60612
University of Illinois at Chicago /ID# 106175
Chicago, Illinois, United States, 60612
Midwestern Regional Medical Center /ID# 60744
Zion, Illinois, United States, 60099
United States, Maryland
Mercy Medical Center /ID# 60748
Baltimore, Maryland, United States, 21202
Johns Hopkins University School of Medicine /ID# 60759
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital /ID# 64582
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center /ID# 94016
Boston, Massachusetts, United States, 02215
Dana Farber Cancer Institute /ID# 93833
Boston, Massachusetts, United States, 02215
United States, Michigan
William Beaumont Hospital /ID# 95417
Royal Oak, Michigan, United States, 48073
United States, Missouri
Washington University School of Medicine /ID# 62724
Saint Louis, Missouri, United States, 63110
United States, New York
Beth Israel Medical Center /ID# 60756
New York, New York, United States, 10003
Beth Israel Medical Center /ID# 87973
New York, New York, United States, 10003
Beth Israel Medical Center /ID# 87993
New York, New York, United States, 10003
Memorial Sloan-Kettering Cancer Center (MSKCC) /ID# 63222
New York, New York, United States, 10021
United States, North Carolina
Duke Cancer Center /ID# 60747
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Penn State Univ and Milton S. Hershey Medical Center /ID# 62723
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania, School of Medicine /ID# 60753
Philadelphia, Pennsylvania, United States, 19104
Magee Womens Hospital of UPMC /ID# 60758
Pittsburgh, Pennsylvania, United States, 15232
University of Pittsburgh Medical Center /ID# 65486
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
South Carolina Medical University /ID# 60752
Charleston, South Carolina, United States, 29425
United States, Tennessee
The West Clinic, dba West Cancer Center /ID# 65487
Germantown, Tennessee, United States, 38138
The West Clinic, dba West Cancer Center /ID# 94601
Germantown, Tennessee, United States, 38138
The West Clinic, dba West Cancer Center /ID# 94599
Memphis, Tennessee, United States, 38120
The West Clinic, dba West Cancer Center /ID# 94600
Memphis, Tennessee, United States, 38120
United States, Texas
UT Southwestern Medical Center /ID# 60745
Dallas, Texas, United States, 75390-8852
The Methodist Hospital /ID# 60742
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute /ID# 115075
Seattle, Washington, United States, 98104
Argentina
Centro de Oncologia e Investigacion Buenos Aires (COIBA) /ID# 65219
Berazategui, Buenos Aires, Argentina, B1884BBF
ISIS Centro Especializado /ID# 65226
Santa Fe, Argentina, S3000FFU
Australia
Royal Adelaide Hospital /ID# 63280
Adelaide, Australia, 5000
Royal Hobart Hospital /ID# 63279
Hobart, Australia, 7000
Mater Hospital /ID# 63276
Milton, Australia, 4064
Peter MacCallum Cancer Centre /ID# 63272
Parkville, Australia, 3000
Royal Melbourne Hospital /ID# 63278
Parkville, Australia, 3052
Mount Hospital /ID# 65262
Perth, Australia, 6000
The Prince of Wales Hospital /ID# 63271
Randwick, Australia, 2031
Southern Medical Day Care Center /ID# 63274
Wollongong, Australia, 2500
Belgium
ZNA Middelheim /ID# 96137
Antwerp, Belgium, 2020
AZ St-Jan Brugge-Oostende AV - Campus Sint Jan /ID# 107315
Bruges, Belgium, 8000
Cliniques Universitaires Saint-Luc /ID# 96135
Brussels, Belgium, 1200
Grand Hopital de Charleroi /ID# 96136
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen /ID# 96945
Edegem, Belgium, 2650
Universitair Ziekenhuis Leuven /ID# 96138
Leuven, Belgium, 3000
Clinique Sainte-Elisabeth (CMSE) /ID# 110595
Namur, Belgium, 5000
Brazil
Hospital Bruno Born /ID# 65247
Lajeado, Brazil, 95900-000
Hospital Clinics of Porto Alegre /ID# 65242
Porto Alegre, Brazil, 90035-903
Irmandade de Santa Casa de Misericordia /ID# 65244
Porto Alegre, Brazil, 90050-170
Canada
Hopital Notre Dame /ID# 67862
Montreal, Canada, H2L 4M1
Jewish General Hospital, Sir Mortimer B. Davis /ID# 69893
Montreal, Canada, H3T 1E2
CHU du Quebec, Hopital du Saint Sacrement (CHUQ) /ID# 68902
Quebec, Canada, G1S 4L8
Sunnybrook Health Sciences Centre /ID# 77373
Toronto, Canada, M4N 3M5
Czechia
Masarykuv onkologicky ustav /ID# 65170
Brno, Czechia, 656 53
Palacky University /ID# 63923
Olomouc, Czechia, 775 20
Vseobecna Fakultni Nemocnice a I. LF UK v Praze /ID# 65172
Prague 2, Czechia, 128 08
Denmark
Rigshospitalet, Finsen Centre /ID# 67822
Copenhagen, Denmark, DK 2100
Vejle Sygehus /ID# 65173
Vejle, Denmark, 7100
Finland
Docrates Cancer Center /ID# 63924
Helsinki, Finland, 00180
Tampere University Hospital /ID# 102417
Tampere, Finland, 33520
France
Centre d`Oncology et de Radiotherapie du Pays-Basque /ID# 65176
Bayonne, France, 64100
Centre Leon Berard /ID# 106675
Lyon, Cedex 8, France, 69373
Institut Paoli-Calmettes /ID# 65175
Marseille Cedex 09, France, 13009
Institut Curie /ID# 63926
Paris, France, 75005
Hopital Rene Huguenin, Institut Curie /ID# 65177
Saint Cloud, France, 92210
Insititut de Cancerologie de l'Ouest -Centre Rene Gauducheau /ID# 63927
Saint Herblain, France, 44800
Centre Paul Strauss /ID# 100275
Strasbourg Cedex, France, 67065
Institut Claudius Regaud /ID# 98815
Toulouse, Cedex 09, France, 31059
Hungary
Bajcsy-Zsilinszky Korhaz /ID# 65179
Budapest, Hungary, 1106
Debreceni Egyetem /ID# 65178
Debrecen, Hungary, 4032
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 63928
Szolnok, Hungary, 5000
Israel
Soroka University Medical Center /ID# 65180
Be'er-Sheva, Israel, 84101
Rambam Health Care Campus /ID# 63930
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 116575
Jerusalem, Israel, 91031-02
Hadassah University Hospital /ID# 63931
Jerusalem, Israel, 91120
Rabin Medical Center /ID# 63929
Petah Tikva, Israel, 49100
The Chaim Sheba Medical Center /ID# 63932
Ramat Gan, Israel, 5265601
Kaplan Medical Center /ID# 63933
Rehovot, Israel, 76100
Assaf Harofeh Medical Center /ID# 65181
Zerifin, Israel, 70300
Netherlands
Erasmus Medisch Centrum /ID# 96275
Rotterdam, Netherlands, 3075 EA
Norway
Haukeland University Hospital /ID# 67982
Bergen, Norway, 5021
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka /ID# 73393
Bydgoszcz, Poland, 85-796
Olsztynski Osrodek Onkologiczny Kopernik /ID# 71060
Olsztyn, Poland, 10513
NZOZ Centrum Medyczne HCP /ID# 68102
Poznan, Poland, 61-485
Wielkopolskie Centrum Onkologii /ID# 71061
Poznan, Poland, 61-866
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975
Rzeszow, Poland, 35-085
Romania
S.C. lanuli Med Consult SRL /ID# 106955
Bucharest, Romania, 010976
lnstitutul Oncologic Prof. Dr. Alexandru Trestioreanu /ID# 96742
Bucharest, Romania, 022328
Institute of Oncology Prof. Dr. I. Chiricuta /ID# 96740
Cluj-Napoca, Romania, 400015
Spitalul Clinic Judetean de Urgenta Cluj-Napoca /ID# 96741
Cluj-Napoca, Romania, 400349
Sc Oncolab Srl /Id# 96745
Craiova, Romania, 200385
Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary /ID# 63938
Chelyabinsk, Russian Federation, 454087
Russian Cancer Research Center n.a. N.N. Blokhin RAMS /ID# 65263
Moscow, Russian Federation, 115478
Murmansk Regional Oncology Dispensary /ID# 102415
Murmansk, Russian Federation, 183047
City Clinical Hospital 1 /ID# 102416
Novosibirsk, Russian Federation, 630047
Pyatigorsk Oncology Dispensary /ID# 65264
Pyatigorsk, Russian Federation, 357052
St. Petersburg State Budgetary Institution of Healthcare /ID# 65265
St. Petersburg, Russian Federation, 197022
N.N. Petrov Research Institute of Oncology /ID# 65269
St. Petersburg, Russian Federation, 197758
N.N. Petrov Research Institute of Oncology /ID# 78973
St. Petersburg, Russian Federation, 197758
Volgograd Regional Oncological Dispensary # 3 /ID# 98035
Volzhskiy, Russian Federation, 404130
Spain
Hospital Vall d'Hebron /ID# 97415
Bacelona, Spain, 08035
Hospital Santa Creu i Sant Pau /ID# 97418
Barcelona, Spain, 08026
Hospital General Universitario Gregorio Maranon /ID# 97417
Madrid, Spain, 28007
Hospital Universitario Madrid Sanchinarro /ID# 97416
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de la Victoria /ID# 97976
Malaga, Spain, 29010
Hospital Clinico Universitario de Valencia /ID# 97975
Valencia, Spain, 46010
Sweden
Sahlgrenska University Hospital /ID# 97715
Gothenburg, Sweden, 413 45
Skanes Universitetssjukhus /ID# 96475
Malmo, Sweden, SE-205 02
Karolinska University Hospital, Solna /ID# 98037
Stockholm, Sweden, 171 76
Ukraine
Cherkassy Regional Oncology Ctr Cherkassy Regional Counsel /ID# 97698
Cherkassy, Ukraine, 18009
City Multi-Field Clinical Hospital #4 of Dnipropetrovsk /ID# 63940
Dnepropetrovsk, Ukraine, 49102
Kharkiv Regional Clinical Oncology Center /ID# 97696
Kharkiv, Ukraine, 61070
Lviv State Oncology Local Treatment and Diagnostic Centre /ID# 63941
Lviv, Ukraine, 79031
Odessa National Medical University Clinic /ID# 65278
Odessa, Ukraine, 65009
Poltava Regional Clinical Oncology Center /ID# 97697
Poltava, Ukraine, 36011
Sumy Regional Clinical Oncology Center /ID# 65280
Sumy, Ukraine, 40022
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Ewelina Morawa, MD AbbVie
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01506609     History of Changes
Other Study ID Numbers: M12-895
2011-002913-12 ( EudraCT Number )
Study First Received: January 6, 2012
Last Updated: July 14, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Metastatic breast cancer
Recurrent breast cancer
Breast cancer
temozolomide
Temodar
Paclitaxel
BRCA1 mutation carrier
TMZ
Carboplatin
ABT-888
veliparib
Locally recurrent
Temodal
BRCA2 mutation carrier
PARP

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Temozolomide
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Dacarbazine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 25, 2017