Trial record 1 of 1 for:    AbbVie M12-895
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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: April 14, 2016
Last verified: April 2016
  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: 290
Study Start Date: January 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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
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

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 62994
Birmingham, Alabama, United States, 35249-3300
United States, Arizona
Site Reference ID/Investigator# 118695
Gilbert, Arizona, United States, 85234
United States, Arkansas
Site Reference ID/Investigator# 60750
Little Rock, Arkansas, United States, 72205
United States, California
Site Reference ID/Investigator# 60754
La Jolla, California, United States, 92093
Site Reference ID/Investigator# 60743
Los Angeles, California, United States, 90025
Site Reference ID/Investigator# 93813
Los Angeles, California, United States, 90025
Site Reference ID/Investigator# 60760
Los Angeles, California, United States, 90048
Site Reference ID/Investigator# 96549
Los Angeles, California, United States, 90048
Site Reference ID/Investigator# 65488
Stanford, California, United States, 94305-5826
United States, Colorado
Site Reference ID/Investigator# 60751
Aurora, Colorado, United States, 80045
United States, Florida
Site Reference ID/Investigator# 60749
Boca Raton, Florida, United States, 33486
Site Reference ID/Investigator# 62995
Fort Lauderdale, Florida, United States, 33308
Site Reference ID/Investigator# 60746
Tampa, Florida, United States, 33612
Site Reference ID/Investigator# 60762
West Palm Beach, Florida, United States, 33401
United States, Georgia
Site Reference ID/Investigator# 109395
Atlanta, Georgia, United States, 30322
Site Reference ID/Investigator# 118696
Decatur, Georgia, United States, 30033
United States, Illinois
Site Reference ID/Investigator# 60755
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 106175
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 65489
Chicago, Illinois, United States, 60612
Site Reference ID/Investigator# 95976
Evanston, Illinois, United States, 60201
Site Reference ID/Investigator# 60744
Zion, Illinois, United States, 60099
United States, Maryland
Site Reference ID/Investigator# 60748
Baltimore, Maryland, United States, 21202
Site Reference ID/Investigator# 60759
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Site Reference ID/Investigator# 64582
Boston, Massachusetts, United States, 02114
Site Reference ID/Investigator# 93833
Boston, Massachusetts, United States, 02215
Site Reference ID/Investigator# 94016
Boston, Massachusetts, United States, 02215
United States, Michigan
Site Reference ID/Investigator# 71193
Lansing, Michigan, United States, 48912
Site Reference ID/Investigator# 95417
Royal Oak, Michigan, United States, 48073
United States, Missouri
Site Reference ID/Investigator# 62724
St. Louis, Missouri, United States, 63110
Site Reference ID/Investigator# 94602
St. Louis, Missouri, United States, 63110
Site Reference ID/Investigator# 94603
St. Louis, Missouri, United States, 63110
United States, New York
Site Reference ID/Investigator# 60756
New York, New York, United States, 10003
Site Reference ID/Investigator# 87973
New York, New York, United States, 10003
Site Reference ID/Investigator# 87993
New York, New York, United States, 10003
Site Reference ID/Investigator# 63222
New York, New York, United States, 10021
United States, North Carolina
Site Reference ID/Investigator# 60747
Durham, North Carolina, United States, 27710
United States, Ohio
Site Reference ID/Investigator# 118777
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Site Reference ID/Investigator# 62723
Hershey, Pennsylvania, United States, 17033
Site Reference ID/Investigator# 60753
Philadelphia, Pennsylvania, United States, 19104
Site Reference ID/Investigator# 60758
Pittsburgh, Pennsylvania, United States, 15213
Site Reference ID/Investigator# 65486
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Site Reference ID/Investigator# 60752
Charleston, South Carolina, United States, 29425
United States, Tennessee
Site Reference ID/Investigator# 65487
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 94601
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 94599
Memphis, Tennessee, United States, 38120
Site Reference ID/Investigator# 94600
Memphis, Tennessee, United States, 38120
United States, Texas
Site Reference ID/Investigator# 60745
Dallas, Texas, United States, 75390-8852
Site Reference ID/Investigator# 60742
Houston, Texas, United States, 77030
United States, Washington
Site Reference ID/Investigator# 115075
Seattle, Washington, United States, 98104
Argentina
Site Reference ID/Investigator# 65219
Berazategui, Buenos Aires, Argentina, B1884BBF
Site Reference ID/Investigator# 65226
Santa Fe, Argentina, S3000FFU
Australia
Site Reference ID/Investigator# 63280
Adelaide, Australia, SA 5000
Site Reference ID/Investigator# 63272
East Melbourne, Australia, 3002
Site Reference ID/Investigator# 63279
Hobart, Australia, 7000
Site Reference ID/Investigator# 63276
Milton, Australia, 4064
Site Reference ID/Investigator# 63278
Parkville, Australia, 3050
Site Reference ID/Investigator# 65262
Perth, Australia, 6000
Site Reference ID/Investigator# 63271
Randwick, Australia, 2031
Site Reference ID/Investigator# 63274
Wollongong, Australia, 2500
Belgium
Site Reference ID/Investigator# 96137
Antwerpen, Belgium, 2020
Site Reference ID/Investigator# 107315
Brugge, Belgium, 8000
Site Reference ID/Investigator# 96135
Bruxelles, Belgium, 1200
Site Reference ID/Investigator# 96136
Bruxelles, Belgium, 1200
Site Reference ID/Investigator# 96945
Edegem, Belgium, 2650
Site Reference ID/Investigator# 96138
Leuven, Belgium, 3000
Site Reference ID/Investigator# 110595
Namur, Belgium, 5000
Brazil
Site Reference ID/Investigator# 65247
Lajeado, Brazil, 95900-000
Site Reference ID/Investigator# 65242
Porto Alegre, Brazil, 90035-903
Site Reference ID/Investigator# 65244
Porto Alegre, Brazil, 90050-170
Canada
Site Reference ID/Investigator# 67862
Montreal, Canada, H2L 4M1
Site Reference ID/Investigator# 69893
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 68902
Quebec, Canada, G1S 4L8
Site Reference ID/Investigator# 77373
Toronto, Canada, M4N 3M5
Czech Republic
Site Reference ID/Investigator# 65170
Brno, Czech Republic, 656 53
Site Reference ID/Investigator# 63923
Olomouc, Czech Republic, 775 20
Site Reference ID/Investigator# 65172
Prague 2, Czech Republic, 128 08
Denmark
Site Reference ID/Investigator# 67822
Copenhagen, Denmark, 2100
Site Reference ID/Investigator# 65173
Vejle, Denmark, 7100
Finland
Site Reference ID/Investigator# 63924
Helsinki, Finland, 00180
Site Reference ID/Investigator# 102417
Tampere, Finland, 33521
France
Site Reference ID/Investigator# 65176
Bayonne, France, 64100
Site Reference ID/Investigator# 106675
Lyon, Cedex 8, France, 69373
Site Reference ID/Investigator# 65175
Marseille Cedex 09, France, 13009
Site Reference ID/Investigator# 63926
Paris, France, 75005
Site Reference ID/Investigator# 65177
Saint Cloud, France, 92210
Site Reference ID/Investigator# 63927
Saint Herblain, France, 44800
Site Reference ID/Investigator# 100275
Strasbourg Cedex, France, 67065
Site Reference ID/Investigator# 98815
Toulouse, Cedex 09, France, 31059
Hungary
Site Reference ID/Investigator# 65179
Budapest, Hungary, 1106
Site Reference ID/Investigator# 65178
Debrecen, Hungary, 4032
Site Reference ID/Investigator# 63928
Szolnok, Hungary, 5000
Israel
Site Reference ID/Investigator# 65180
Be'er-Sheva, Israel, 84101
Site Reference ID/Investigator# 63930
Haifa, Israel, 3109601
Site Reference ID/Investigator# 116575
Jerusalem, Israel, 91031
Site Reference ID/Investigator# 63931
Jerusalem, Israel, 91120
Site Reference ID/Investigator# 63929
Petach Tikva, Israel, 49100
Site Reference ID/Investigator# 63932
Ramat Gan, Israel, 52621
Site Reference ID/Investigator# 63933
Rehovot, Israel, 76100
Site Reference ID/Investigator# 65181
Zerifin, Israel, 70300
Netherlands
Site Reference ID/Investigator# 96275
Rotterdam, Netherlands, 3075 EA
Norway
Site Reference ID/Investigator# 67982
Bergen, Norway, 5021
Poland
Site Reference ID/Investigator# 73393
Bydgoszcz, Poland, 85-796
Site Reference ID/Investigator# 122078
Nadarzyn, Poland, 05-830
Site Reference ID/Investigator# 71060
Olsztyn, Poland, 10513
Site Reference ID/Investigator# 68102
Poznan, Poland, 61-485
Site Reference ID/Investigator# 71061
Poznan, Poland, 61-866
Site Reference ID/Investigator# 94975
Rzeszow, Poland, 35-085
Romania
Site Reference ID/Investigator# 96742
Bucharest, Romania, 022328
Site Reference ID/Investigator# 106955
Bucharest, Romania, 010976
Site Reference ID/Investigator# 96740
Cluj-Napoca, Romania, 400015
Site Reference ID/Investigator# 96741
Cluj-Napoca, Romania, 400349
Site Reference ID/Investigator# 96745
Craiova, Romania, 200385
Russian Federation
Site Reference ID/Investigator# 63938
Chelyabinsk, Russian Federation, 454087
Site Reference ID/Investigator# 65263
Moscow, Russian Federation, 115478
Site Reference ID/Investigator# 102415
Murmansk, Russian Federation, 183047
Site Reference ID/Investigator# 102416
Novosibirsk, Russian Federation, 630047
Site Reference ID/Investigator# 65264
Pyatigorsk, Russian Federation, 357052
Site Reference ID/Investigator# 65265
St. Petersburg, Russian Federation, 197022
Site Reference ID/Investigator# 65269
St. Petersburg, Russian Federation, 197758
Site Reference ID/Investigator# 78973
St. Petersburg, Russian Federation, 197758
Site Reference ID/Investigator# 98035
Volzhskiy, Russian Federation, 404130
Spain
Site Reference ID/Investigator# 97415
Bacelona, Spain, 08035
Site Reference ID/Investigator# 97418
Barcelona, Spain, 08041
Site Reference ID/Investigator# 97417
Madrid, Spain, 28007
Site Reference ID/Investigator# 97416
Madrid, Spain, 28050
Site Reference ID/Investigator# 97976
Malaga, Spain, 29010
Site Reference ID/Investigator# 97975
Valencia, Spain, 46010
Sweden
Site Reference ID/Investigator# 97715
Gothenburg, Sweden, 413 45
Site Reference ID/Investigator# 96475
Malmo, Sweden, 205 02
Site Reference ID/Investigator# 98037
Stockholm, Sweden, 171 76
Site Reference ID/Investigator# 97004
Umea, Sweden, SE-901 85
Ukraine
Site Reference ID/Investigator# 97698
Cherkassy, Ukraine, 18009
Site Reference ID/Investigator# 63940
Dnepropetrovsk, Ukraine, 49102
Site Reference ID/Investigator# 97696
Kharkiv, Ukraine, 61070
Site Reference ID/Investigator# 63941
Lviv, Ukraine, 79031
Site Reference ID/Investigator# 65278
Odessa, Ukraine, 65009
Site Reference ID/Investigator# 97697
Poltava, Ukraine, 36011
Site Reference ID/Investigator# 65280
Sumy, Ukraine, 40022
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stacie P. Shepherd, MD AbbVie
  More Information

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: April 14, 2016
Health Authority: Poland: Ministry of Health
Israel: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
United States: Food and Drug Administration
Romania: National Agency for Medicines and Medical Devices
Spain: Comité Ético de Investigación Clínica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Hungary: National Institute of Pharmacy
Ukraine: Ministry of Health
France: Afssaps - Agence francaise de securite sanitaire des produits de sante (Saint-Denis)
Russia: Ministry of Health of the Russian Federation
Canada: Health Canada
Sweden: Medical Products Agency
Slovakia: State Institute for Drug Control
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Finland: Ministry of Social Affairs and Health
Belgium: Ethics Committee
Czech Republic: State Institute for Drug Control
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Brazil: Ministry of Health
Norway: Norwegian Medicines Agency

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

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

ClinicalTrials.gov processed this record on May 26, 2016