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 currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01506609
First received: January 6, 2012
Last updated: July 25, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

Primary Outcome Measures:
  • Progression -Free Survival [ Time Frame: Radiographic evaluation every 9 weeks, clinical evaluation every cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: From Cycle 1 Day1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]
  • Objective Response Rate [ Time Frame: From Cycle 1 Day 1 until patient's death or 3 years post discontinuation ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]
    CIPN (as assessed by the EORTC QLQ-CIPN20 questionnaire and NCI-CTCAE 4.0 grading for peripheral neuropathy


Estimated Enrollment: 255
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2014 (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 and older
Genders Eligible for Study:   Both
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

Contacts
Contact: Raymond A. Knight, BS (847) 938-1378 raymond.knight@abbvie.com
Contact: Melissa Shah, BS (847) 938-3885 melissa.shah@abbvie.com

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 62994 Recruiting
Birmingham, Alabama, United States, 35249-3300
Principal Investigator: Site Reference ID/Investigator# 62994         
United States, Arizona
Site Reference ID/Investigator# 118695 Recruiting
Gilbert, Arizona, United States, 85234
Principal Investigator: Site Reference ID/Investigator# 118695         
United States, Arkansas
Site Reference ID/Investigator# 60750 Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: Site Reference ID/Investigator# 60750         
United States, California
Site Reference ID/Investigator# 60754 Recruiting
La Jolla, California, United States, 92093-0698
Principal Investigator: Site Reference ID/Investigator# 60754         
Site Reference ID/Investigator# 60760 Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Site Reference ID/Investigator# 60760         
Site Reference ID/Investigator# 93813 Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Site Reference ID/Investigator# 93813         
Site Reference ID/Investigator# 96549 Not yet recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Site Reference ID/Investigator# 96549         
Site Reference ID/Investigator# 60743 Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Site Reference ID/Investigator# 60743         
Site Reference ID/Investigator# 65488 Recruiting
Stanford, California, United States, 94305-5826
Principal Investigator: Site Reference ID/Investigator# 65488         
United States, Colorado
Site Reference ID/Investigator# 60751 Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Site Reference ID/Investigator# 60751         
United States, Florida
Site Reference ID/Investigator# 60749 Recruiting
Boca Raton, Florida, United States, 33486
Principal Investigator: Site Reference ID/Investigator# 60749         
Site Reference ID/Investigator# 62995 Recruiting
Fort Lauderdale, Florida, United States, 33308
Principal Investigator: Site Reference ID/Investigator# 62995         
Site Reference ID/Investigator# 60746 Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Site Reference ID/Investigator# 60746         
Site Reference ID/Investigator# 60762 Recruiting
West Palm Beach, Florida, United States, 33401
Principal Investigator: Site Reference ID/Investigator# 60762         
United States, Georgia
Site Reference ID/Investigator# 109395 Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Site Reference ID/Investigator# 109395         
Site Reference ID/Investigator# 118696 Recruiting
Decatur, Georgia, United States, 30033
Principal Investigator: Site Reference ID/Investigator# 118696         
United States, Illinois
Site Reference ID/Investigator# 60755 Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Site Reference ID/Investigator# 60755         
Site Reference ID/Investigator# 60757 Withdrawn
Chicago, Illinois, United States, 60637-1470
Site Reference ID/Investigator# 106175 Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Site Reference ID/Investigator# 106175         
Site Reference ID/Investigator# 65489 Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Site Reference ID/Investigator# 65489         
Site Reference ID/Investigator# 95976 Recruiting
Evanston, Illinois, United States, 60201
Principal Investigator: Site Reference ID/Investigator# 95976         
Site Reference ID/Investigator# 60744 Recruiting
Zion, Illinois, United States, 60099
Principal Investigator: Site Reference ID/Investigator# 60744         
United States, Kentucky
Site Reference ID/Investigator# 81513 Withdrawn
Louisville, Kentucky, United States, 40245
Site Reference ID/Investigator# 93213 Withdrawn
Louisville, Kentucky, United States, 40245
United States, Maryland
Site Reference ID/Investigator# 60759 Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 60759         
Site Reference ID/Investigator# 91213 Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 91213         
Site Reference ID/Investigator# 113675 Not yet recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 113675         
Site Reference ID/Investigator# 60748 Recruiting
Baltimore, Maryland, United States, 21202
Principal Investigator: Site Reference ID/Investigator# 60748         
Site Reference ID/Investigator# 120804 Not yet recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 120804         
Site Reference ID/Investigator# 92633 Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 92633         
United States, Massachusetts
Site Reference ID/Investigator# 94016 Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Site Reference ID/Investigator# 94016         
Site Reference ID/Investigator# 93833 Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Site Reference ID/Investigator# 93833         
Site Reference ID/Investigator# 64582 Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Site Reference ID/Investigator# 64582         
United States, Michigan
Site Reference ID/Investigator# 71193 Recruiting
Lansing, Michigan, United States, 48912
Principal Investigator: Site Reference ID/Investigator# 71193         
Site Reference ID/Investigator# 95417 Recruiting
Royal Oak, Michigan, United States, 48073
Principal Investigator: Site Reference ID/Investigator# 95417         
United States, Missouri
Site Reference ID/Investigator# 113355 Withdrawn
St. Louis, Missouri, United States, 63110
Site Reference ID/Investigator# 62724 Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Site Reference ID/Investigator# 62724         
Site Reference ID/Investigator# 94602 Not yet recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Site Reference ID/Investigator# 94602         
Site Reference ID/Investigator# 103999 Withdrawn
St. Louis, Missouri, United States, 63110
Site Reference ID/Investigator# 94603 Not yet recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Site Reference ID/Investigator# 94603         
United States, New Jersey
Site Reference ID/Investigator# 62783 Recruiting
New Brunswick, New Jersey, United States, 08903
Principal Investigator: Site Reference ID/Investigator# 62783         
United States, New York
Site Reference ID/Investigator# 63222 Recruiting
New York, New York, United States, 10021
Principal Investigator: Site Reference ID/Investigator# 63222         
Site Reference ID/Investigator# 87993 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 87993         
Site Reference ID/Investigator# 60756 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 60756         
Site Reference ID/Investigator# 87973 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 87973         
United States, North Carolina
Site Reference ID/Investigator# 60747 Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Site Reference ID/Investigator# 60747         
United States, Ohio
Site Reference ID/Investigator# 118777 Not yet recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Site Reference ID/Investigator# 118777         
United States, Pennsylvania
Site Reference ID/Investigator# 62723 Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Principal Investigator: Site Reference ID/Investigator# 62723         
Site Reference ID/Investigator# 60753 Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Site Reference ID/Investigator# 60753         
Site Reference ID/Investigator# 65486 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Site Reference ID/Investigator# 65486         
Site Reference ID/Investigator# 92213 Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Site Reference ID/Investigator# 92213         
Site Reference ID/Investigator# 60758 Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Site Reference ID/Investigator# 60758         
United States, South Carolina
Site Reference ID/Investigator# 60752 Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Site Reference ID/Investigator# 60752         
United States, Tennessee
Site Reference ID/Investigator# 94599 Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 94599         
Site Reference ID/Investigator# 94601 Not yet recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 94601         
Site Reference ID/Investigator# 65487 Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 65487         
Site Reference ID/Investigator# 94600 Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 94600         
United States, Texas
Site Reference ID/Investigator# 60745 Recruiting
Dallas, Texas, United States, 75390-9032
Principal Investigator: Site Reference ID/Investigator# 60745         
Site Reference ID/Investigator# 60742 Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Site Reference ID/Investigator# 60742         
United States, Utah
Site Reference ID/Investigator# 62722 Withdrawn
Salt Lake City, Utah, United States, 84112
United States, Washington
Site Reference ID/Investigator# 115075 Recruiting
Seattle, Washington, United States, 98104
Principal Investigator: Site Reference ID/Investigator# 115075         
Argentina
Site Reference ID/Investigator# 65219 Recruiting
Buenos Aires, Argentina, B1884BBF
Principal Investigator: Site Reference ID/Investigator# 65219         
Site Reference ID/Investigator# 65226 Recruiting
Santa Fe, Argentina, S3000FFU
Principal Investigator: Site Reference ID/Investigator# 65226         
Australia
Site Reference ID/Investigator# 63280 Recruiting
Adelaide, Australia, 5000
Principal Investigator: Site Reference ID/Investigator# 63280         
Site Reference ID/Investigator# 63272 Recruiting
East Melbourne, Australia, 3002
Principal Investigator: Site Reference ID/Investigator# 63272         
Site Reference ID/Investigator# 63279 Recruiting
Hobart, Australia, 7000
Principal Investigator: Site Reference ID/Investigator# 63279         
Site Reference ID/Investigator# 63276 Completed
Milton, Australia, 4064
Site Reference ID/Investigator# 63278 Recruiting
Parkville, Australia, 3050
Principal Investigator: Site Reference ID/Investigator# 63278         
Site Reference ID/Investigator# 65262 Recruiting
Perth, Australia, 6000
Principal Investigator: Site Reference ID/Investigator# 65262         
Site Reference ID/Investigator# 63271 Recruiting
Randwick, Australia, 2031
Principal Investigator: Site Reference ID/Investigator# 63271         
Site Reference ID/Investigator# 63273 Recruiting
Westmead, Australia, 2145
Principal Investigator: Site Reference ID/Investigator# 63273         
Site Reference ID/Investigator# 63274 Recruiting
Wollongong, Australia, 2500
Principal Investigator: Site Reference ID/Investigator# 63274         
Belgium
Site Reference ID/Investigator# 96137 Recruiting
Antwerp, Belgium, 2020
Principal Investigator: Site Reference ID/Investigator# 96137         
Site Reference ID/Investigator# 107315 Recruiting
Brugge, Belgium, 8000
Principal Investigator: Site Reference ID/Investigator# 107315         
Site Reference ID/Investigator# 96136 Recruiting
Brussels, Belgium, 1200
Principal Investigator: Site Reference ID/Investigator# 96136         
Site Reference ID/Investigator# 96135 Recruiting
Brussels, Belgium, 1200
Principal Investigator: Site Reference ID/Investigator# 96135         
Site Reference ID/Investigator# 96945 Recruiting
Edegem, Belgium, 2650
Principal Investigator: Site Reference ID/Investigator# 96945         
Site Reference ID/Investigator# 96138 Recruiting
Leuven, Belgium, 3000
Principal Investigator: Site Reference ID/Investigator# 96138         
Site Reference ID/Investigator# 110595 Recruiting
Namur, Belgium, 5000
Principal Investigator: Site Reference ID/Investigator# 110595         
Brazil
Site Reference ID/Investigator# 65247 Recruiting
Lajeado, Brazil, 95900-000
Principal Investigator: Site Reference ID/Investigator# 65247         
Site Reference ID/Investigator# 65242 Recruiting
Porto Alegre, Brazil, 90035-903
Principal Investigator: Site Reference ID/Investigator# 65242         
Site Reference ID/Investigator# 65244 Recruiting
Porto Alegre, Brazil, 90050-170
Principal Investigator: Site Reference ID/Investigator# 65244         
Canada
Site Reference ID/Investigator# 67862 Recruiting
Montreal, Canada, H2L 4M1
Principal Investigator: Site Reference ID/Investigator# 67862         
Site Reference ID/Investigator# 69893 Recruiting
Montreal, Canada, H3T 1E2
Principal Investigator: Site Reference ID/Investigator# 69893         
Site Reference ID/Investigator# 68902 Recruiting
Quebec City, Canada, G1S 4L8
Principal Investigator: Site Reference ID/Investigator# 68902         
Site Reference ID/Investigator# 77373 Recruiting
Toronto, Canada, M4N 3M5
Principal Investigator: Site Reference ID/Investigator# 77373         
Czech Republic
Site Reference ID/Investigator# 65170 Recruiting
Brno, Czech Republic, 656 53
Principal Investigator: Site Reference ID/Investigator# 65170         
Site Reference ID/Investigator# 63923 Recruiting
Olomouc, Czech Republic, 775 20
Principal Investigator: Site Reference ID/Investigator# 63923         
Site Reference ID/Investigator# 65172 Recruiting
Prague 2, Czech Republic, 12808
Principal Investigator: Site Reference ID/Investigator# 65172         
Denmark
Site Reference ID/Investigator# 67822 Recruiting
Copenhagen, Denmark, 2100
Principal Investigator: Site Reference ID/Investigator# 67822         
Site Reference ID/Investigator# 65173 Recruiting
Vejle, Denmark, 7100
Principal Investigator: Site Reference ID/Investigator# 65173         
Finland
Site Reference ID/Investigator# 63924 Recruiting
Helsinki, Finland, 00180
Principal Investigator: Site Reference ID/Investigator# 63924         
Site Reference ID/Investigator# 65174 Not yet recruiting
Helsinki, Finland, 00290
Principal Investigator: Site Reference ID/Investigator# 65174         
Site Reference ID/Investigator# 102417 Recruiting
Tampere, Finland, 33520
Principal Investigator: Site Reference ID/Investigator# 102417         
France
Site Reference ID/Investigator# 65176 Recruiting
Bayonne, France, 64100
Principal Investigator: Site Reference ID/Investigator# 65176         
Site Reference ID/Investigator# 106675 Recruiting
Lyon Cedex 08, France, 69373
Principal Investigator: Site Reference ID/Investigator# 106675         
Site Reference ID/Investigator# 65175 Recruiting
Marseille, France, 13009
Principal Investigator: Site Reference ID/Investigator# 65175         
Site Reference ID/Investigator# 63926 Recruiting
Paris Cedex 05, France, 75248
Principal Investigator: Site Reference ID/Investigator# 63926         
Site Reference ID/Investigator# 65177 Recruiting
Saint Cloud, France, 92210
Principal Investigator: Site Reference ID/Investigator# 65177         
Site Reference ID/Investigator# 63927 Recruiting
Saint Herblain, France, 44805
Principal Investigator: Site Reference ID/Investigator# 63927         
Site Reference ID/Investigator# 100275 Recruiting
Strasbourg Cedex, France, 67065
Principal Investigator: Site Reference ID/Investigator# 100275         
Site Reference ID/Investigator# 98815 Recruiting
Toulouse Cedex 9, France, 31059
Principal Investigator: Site Reference ID/Investigator# 98815         
Site Reference ID/Investigator# 63925 Withdrawn
Villejuif, France, 94805
Hungary
Site Reference ID/Investigator# 65179 Recruiting
Budapest, Hungary, 1106
Principal Investigator: Site Reference ID/Investigator# 65179         
Site Reference ID/Investigator# 65178 Recruiting
Debrecen, Hungary, 4032
Principal Investigator: Site Reference ID/Investigator# 65178         
Site Reference ID/Investigator# 63928 Recruiting
Szolnok, Hungary, 5004
Principal Investigator: Site Reference ID/Investigator# 63928         
Israel
Site Reference ID/Investigator# 65180 Recruiting
Be'er-Sheva, Israel, 84802
Principal Investigator: Site Reference ID/Investigator# 65180         
Site Reference ID/Investigator# 63930 Recruiting
Haifa, Israel, 31096
Principal Investigator: Site Reference ID/Investigator# 63930         
Site Reference ID/Investigator# 116575 Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Site Reference ID/Investigator# 116575         
Site Reference ID/Investigator# 63931 Recruiting
Jerusalem, Israel, 9112001
Principal Investigator: Site Reference ID/Investigator# 63931         
Site Reference ID/Investigator# 63929 Recruiting
Petach Tikva, Israel, PETACH TIQWA
Principal Investigator: Site Reference ID/Investigator# 63929         
Site Reference ID/Investigator# 63933 Recruiting
Rehovot, Israel, 76100
Principal Investigator: Site Reference ID/Investigator# 63933         
Site Reference ID/Investigator# 63932 Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Site Reference ID/Investigator# 63932         
Site Reference ID/Investigator# 65181 Recruiting
Zerifin, Israel, 70300
Principal Investigator: Site Reference ID/Investigator# 65181         
Netherlands
Site Reference ID/Investigator# 96277 Recruiting
Nijmegen, Netherlands, 6525 GA
Principal Investigator: Site Reference ID/Investigator# 96277         
Site Reference ID/Investigator# 96275 Recruiting
Rotterdam, Netherlands, 3075 EA
Principal Investigator: Site Reference ID/Investigator# 96275         
Norway
Site Reference ID/Investigator# 67982 Recruiting
Bergen, Norway, 5021
Principal Investigator: Site Reference ID/Investigator# 67982         
Poland
Site Reference ID/Investigator# 73393 Recruiting
Bydgoszcz, Poland, 85-796
Principal Investigator: Site Reference ID/Investigator# 73393         
Site Reference ID/Investigator# 122078 Recruiting
Nadarzyn, Poland, 05-830
Principal Investigator: Site Reference ID/Investigator# 122078         
Site Reference ID/Investigator# 71060 Recruiting
Olsztyn, Poland, 10513
Principal Investigator: Site Reference ID/Investigator# 71060         
Site Reference ID/Investigator# 71061 Recruiting
Poznan, Poland, 61-866
Principal Investigator: Site Reference ID/Investigator# 71061         
Site Reference ID/Investigator# 68102 Recruiting
Poznan, Poland, 61-485
Principal Investigator: Site Reference ID/Investigator# 68102         
Site Reference ID/Investigator# 94975 Recruiting
Rzeszow, Poland, 35-085
Principal Investigator: Site Reference ID/Investigator# 94975         
Romania
Site Reference ID/Investigator# 101535 Recruiting
Brasov, Romania, 500091
Principal Investigator: Site Reference ID/Investigator# 101535         
Site Reference ID/Investigator# 106955 Recruiting
Bucharest, Romania, 010976
Principal Investigator: Site Reference ID/Investigator# 106955         
Site Reference ID/Investigator# 96742 Recruiting
Bucharest, Romania, 022328
Principal Investigator: Site Reference ID/Investigator# 96742         
Site Reference ID/Investigator# 96740 Recruiting
Cluj-Napoca, Romania, 400015
Principal Investigator: Site Reference ID/Investigator# 96740         
Site Reference ID/Investigator# 96741 Recruiting
Cluj-Napoca, Romania, 400206
Principal Investigator: Site Reference ID/Investigator# 96741         
Site Reference ID/Investigator# 96745 Recruiting
Craiova, Romania, 200385
Principal Investigator: Site Reference ID/Investigator# 96745         
Russian Federation
Site Reference ID/Investigator# 63938 Recruiting
Chelyabinsk, Russian Federation, 454087
Principal Investigator: Site Reference ID/Investigator# 63938         
Site Reference ID/Investigator# 65263 Recruiting
Moscow, Russian Federation, 115478
Principal Investigator: Site Reference ID/Investigator# 65263         
Site Reference ID/Investigator# 102415 Recruiting
Murmansk, Russian Federation, 183047
Principal Investigator: Site Reference ID/Investigator# 102415         
Site Reference ID/Investigator# 102416 Recruiting
Novosibirsk, Russian Federation, 630047
Principal Investigator: Site Reference ID/Investigator# 102416         
Site Reference ID/Investigator# 65264 Recruiting
Pyatigorsk, Russian Federation, 357052
Principal Investigator: Site Reference ID/Investigator# 65264         
Site Reference ID/Investigator# 65269 Recruiting
St. Petersburg, Russian Federation, 197758
Principal Investigator: Site Reference ID/Investigator# 65269         
Site Reference ID/Investigator# 78973 Recruiting
St. Petersburg, Russian Federation, 197758
Principal Investigator: Site Reference ID/Investigator# 78973         
Site Reference ID/Investigator# 65265 Recruiting
St. Petersburg, Russian Federation, 197022
Principal Investigator: Site Reference ID/Investigator# 65265         
Site Reference ID/Investigator# 98035 Recruiting
Volzhskiy, Russian Federation, 404133
Principal Investigator: Site Reference ID/Investigator# 98035         
Slovakia
Site Reference ID/Investigator# 65274 Withdrawn
Nitra, Slovakia, 94911
Spain
Site Reference ID/Investigator# 97415 Recruiting
Bacelona, Spain, 08035
Principal Investigator: Site Reference ID/Investigator# 97415         
Site Reference ID/Investigator# 97418 Recruiting
Barcelona, Spain, 08041
Principal Investigator: Site Reference ID/Investigator# 97418         
Site Reference ID/Investigator# 97416 Recruiting
Madrid, Spain, 28050
Principal Investigator: Site Reference ID/Investigator# 97416         
Site Reference ID/Investigator# 97417 Recruiting
Madrid, Spain, 28007
Principal Investigator: Site Reference ID/Investigator# 97417         
Site Reference ID/Investigator# 97976 Recruiting
Malaga, Spain, 29010
Principal Investigator: Site Reference ID/Investigator# 97976         
Site Reference ID/Investigator# 97975 Recruiting
Valencia, Spain, 46010
Principal Investigator: Site Reference ID/Investigator# 97975         
Sweden
Site Reference ID/Investigator# 97715 Recruiting
Gothenburg, Sweden, 413 45
Principal Investigator: Site Reference ID/Investigator# 97715         
Site Reference ID/Investigator# 96475 Recruiting
Malmo, Sweden, 205 02
Principal Investigator: Site Reference ID/Investigator# 96475         
Site Reference ID/Investigator# 98037 Recruiting
Stockholm, Sweden, 171 76
Principal Investigator: Site Reference ID/Investigator# 98037         
Site Reference ID/Investigator# 97004 Recruiting
Umea, Sweden, 90185
Principal Investigator: Site Reference ID/Investigator# 97004         
Ukraine
Site Reference ID/Investigator# 97698 Recruiting
Cherkassy, Ukraine, 18009
Principal Investigator: Site Reference ID/Investigator# 97698         
Site Reference ID/Investigator# 63940 Recruiting
Dnepropetrovsk, Ukraine, 49102
Principal Investigator: Site Reference ID/Investigator# 63940         
Site Reference ID/Investigator# 97696 Recruiting
Kharkiv, Ukraine, 61070
Principal Investigator: Site Reference ID/Investigator# 97696         
Site Reference ID/Investigator# 63941 Recruiting
Lviv, Ukraine, 79031
Principal Investigator: Site Reference ID/Investigator# 63941         
Site Reference ID/Investigator# 65278 Recruiting
Odessa, Ukraine, 65009
Principal Investigator: Site Reference ID/Investigator# 65278         
Site Reference ID/Investigator# 97697 Recruiting
Poltava, Ukraine, 36011
Principal Investigator: Site Reference ID/Investigator# 97697         
Site Reference ID/Investigator# 65280 Recruiting
Sumy, Ukraine, 40022
Principal Investigator: Site Reference ID/Investigator# 65280         
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stacie P. Shepherd, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01506609     History of Changes
Other Study ID Numbers: M12-895, 2011-002913-12
Study First Received: January 6, 2012
Last Updated: July 25, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
Finland: Ministry of Social Affairs and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Canada: Health Canada
Russia: Ministry of Health of the Russian Federation
Israel: Ministry of Health
Norway: Norwegian Medicines Agency
Poland: Ministry of Health
Ukraine: Ministry of Health
Spain: Comité Ético de Investigación Clínica
Sweden: Medical Products Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Romania: National Agency for Medicines and Medical Devices

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Dacarbazine
Paclitaxel
Temozolomide
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014