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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

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ClinicalTrials.gov Identifier: NCT01506609
Recruitment Status : Active, not recruiting
First Posted : January 10, 2012
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Placebo Drug: Veliparib Drug: Carboplatin Drug: Temozolomide Drug: Paclitaxel Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date : January 24, 2012
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

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: Placebo
Placebo comparator for Veliparib days 1 through 7 of 21-day cycle (in combination with carboplatin and/or paclitaxel).

Drug: Carboplatin
Day 3 of 21-day cycle

Drug: Paclitaxel
Day 3 of 21-day cycle.
Other Name: Taxol

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




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

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

Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506609


  Hide Study Locations
Locations
United States, Alabama
University of Alabama /ID# 62994
Birmingham, Alabama, United States, 35233
United States, Arizona
Banner MD Anderson Cancer Ctr /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
Cedars-Sinai Medical Center /ID# 96549
Beverly Hills, California, United States, 90211
Ucsd /Id# 60754
La Jolla, California, United States, 92037
The Angeles Clinic and Researc /ID# 60743
Los Angeles, California, United States, 90025
The Angeles Clinic and Researc /ID# 93813
Los Angeles, California, United States, 90025
Cedars-Sinai Medical Ctr /ID# 60760
Los Angeles, California, United States, 90048
Stanford Univ School of Med /ID# 65488
Stanford, California, United States, 94305-2200
United States, Colorado
Univ of Colorado Cancer Center /ID# 60751
Aurora, Colorado, United States, 80045
United States, Florida
Lynn Cancer Institute, Boca /ID# 60749
Boca Raton, Florida, United States, 33486
Holy Cross Hospital /ID# 62995
Fort Lauderdale, Florida, United States, 33308
Moffitt Cancer Center /ID# 60746
Tampa, Florida, United States, 33612
Florida Cancer Specialists - East /ID# 60762
West Palm Beach, Florida, United States, 33401
United States, Illinois
University of Illinois /ID# 106175
Chicago, Illinois, United States, 60607
Northwestern University /ID# 60755
Chicago, Illinois, United States, 60611-2927
Rush University Medical Center /ID# 65489
Chicago, Illinois, United States, 60612
Midwestern Regional CTC /ID# 60744
Zion, Illinois, United States, 60099
United States, Maryland
Johns Hopkins University /ID# 60759
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital /ID# 64582
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute /ID# 93833
Boston, Massachusetts, United States, 02215
United States, Michigan
William Beaumont Hospital /ID# 95417
Royal Oak, Michigan, United States, 48073-6710
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# 87993
New York, New York, United States, 10003
Memorial Sloan Kettering Cancer Center /ID# 63222
New York, New York, United States, 10065-6007
United States, North Carolina
Duke Univ Med Ctr /ID# 60747
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Penn State University and Milton S. Hershey Medical Center /ID# 62723
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania /ID# 60753
Philadelphia, Pennsylvania, United States, 19104-5502
University of Pittsburgh MC /ID# 60758
Pittsburgh, Pennsylvania, United States, 15260
University of Pittsburgh MC /ID# 65486
Pittsburgh, Pennsylvania, United States, 15260
United States, South Carolina
Med Univ of South Carolina /ID# 60752
Charleston, South Carolina, United States, 29425
United States, Tennessee
The West Clinic /ID# 65487
Memphis, Tennessee, United States, 38120
The West Clinic /ID# 94599
Memphis, Tennessee, United States, 38120
The West Clinic /ID# 94600
Memphis, Tennessee, United States, 38120
United States, Texas
UT Southwestern Medical Center /ID# 60745
Dallas, Texas, United States, 75390-7208
The Methodist Hospital /ID# 60742
Houston, Texas, United States, 77030
Argentina
Coiba /Id# 65219
Berazategui, Buenos Aires, Argentina, 1884
ISIS Centro Especializado /ID# 65226
Santa Fe, Argentina, 3000
Australia, New South Wales
The Prince of Wales Hospital /ID# 63271
Randwick, New South Wales, Australia, 2031
Southern Medical Day Care Ctr /ID# 63274
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Mater Health Hospital /ID# 63276
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
Royal Adelaide Hospital /ID# 63280
Adelaide, South Australia, Australia, 5000
Australia, Tasmania
Royal Hobart Hospital /ID# 63279
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Peter MacCallum Cancer Ctr /ID# 63272
Melbourne, Victoria, Australia, 3000
Royal Melbourne Hospital /ID# 63278
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Mount Hospital /ID# 65262
Perth, Western Australia, Australia, 6000
Belgium
Cliniques Universitaires Saint Luc /ID# 96135
Woluwe-Saint-Lambert, Bruxelles-Capitale, Belgium, 1200
Grand Hôpital de Charleroi /ID# 96136
Charleroi, Hainaut, Belgium, 6000
AZ St-Jan Brugge-Oostende AV /ID# 107315
Brugge, West-Vlaanderen, Belgium, 8000
UZ Antwerp /ID# 96945
Edegem, Belgium, 2650
UZ Leuven /ID# 96138
Leuven, Belgium, 3000
CHU UCL Namur /ID# 110595
Namur, Belgium, 5000
Brazil
Hospital Bruno Born /ID# 65247
Lajeado, Rio Grande Do Sul, Brazil, 95900-000
Irmandade da Santa Casa de /ID# 65244
Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
Hospital de Clinicas de Porto Alegre /ID# 65242
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Canada, Ontario
Sunnybrook Health Sciences Ctr /ID# 77373
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Jewish General Hospital /ID# 69893
Montreal, Quebec, Canada, H3T 1E2
CHUM - Notre-Dame Hospital /ID# 67862
Montréal, Quebec, Canada, H2X 0A9
CHUQ-Hospital St. Sacrement /ID# 68902
Quebec City, Quebec, Canada, G1S 4L8
Czechia
Masarykuv onkologikcy ustav /ID# 65170
Brno, Czechia, 656 53
Palacky University /ID# 63923
Olomouc, Czechia, 779 00
Vseobecna Fakultni Nemocnice /ID# 65172
Prague, Czechia, 128 08
Denmark
Vejle Sygehus /ID# 65173
Vejle, Syddanmark, Denmark, 7100
Rigshospitalet, Finsen Centre /ID# 67822
Copenhagen, Denmark, 2100
Finland
Docrates Cancer Center /ID# 63924
Helsinki, Finland, 00180
Tampere University Hospital /ID# 102417
Tampere, Finland, 33521
France
Hopital Universitaire Purpan /ID# 98815
Toulouse, Haute-Garonne, France, 31059
Institut de Cancer de l'Ouest /ID# 63927
St Herblain CEDEX, Loire-Atlantique, France, 44805
Centre Leon Berard /ID# 106675
Lyon CEDEX 08, Rhone, France, 69373
Pays-Basque Ctr Oncology/Radio /ID# 65176
Bayonne, France, 64100
Institut Paoli-Calmettes /ID# 65175
Marseille, France, 13273
Institut Curie /ID# 63926
Paris, France, 75248
Hopital Rene Huguenin /ID# 65177
Saint-cloud, France, 92210
Centre Paul Strauss /ID# 100275
Strasbourg, France, 67065
Hungary
Bajcsy-Zsilinszky Korhaz /ID# 65179
Budapest, Hungary, 1106
Debreceni Egyetem Klinikai Koz /ID# 65178
Debrecen, Hungary, 4032
Jasz-Nagykun-Szolnok Megyei /ID# 63928
Szolnok, Hungary, 5004
Israel
Rabin Medical Center /ID# 63929
Petakh Tikva, Tel-Aviv, Israel, 4941492
Soroka Medical Ctr /ID# 65180
Be'er Sheva, Israel, 84101
Assaf Harofeh Medical Center /ID# 65181
Be'er Ya'akov, Israel, 70300
Rambam Health Care Campus /ID# 63930
Haifa, Israel, 3109601
Shaare Zedek Medical Center /ID# 116575
Jerusalem, Israel, 91031
Hadassah University Hospital /ID# 63931
Jerusalem, Israel, 91120
Sheba Medical Center /ID# 63932
Ramat Gan, Israel, 5262100
Kaplan Medical Center /ID# 63933
Rehovot, Israel, 76100
Netherlands
Erasmus Medisch Centrum /ID# 96275
Rotterdam, Netherlands, 3015 CE
Norway
Haukeland University Hospital /ID# 67982
Bergen, Hordaland, Norway, 5021
Poland
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 94975
Rzeszów, Podkarpackie, Poland, 35-021
Centrum Onkologii Lukaszczyka /ID# 73393
Bydgoszcz, Poland, 85-796
Olsztynski Osrodek Onkologi /ID# 71060
Olsztyn, Poland, 10-513
NZOZ Centrum Medyczne HCP /ID# 68102
Poznan, Poland, 61-485
Wielkopolskie Centrum Onkologi /ID# 71061
Poznan, Poland, 61-866
Romania
S.C. lanuli Med Consult SRL /ID# 106955
Bucharest, Romania, 020962
lnstitutul Oncologic Trestiore /ID# 96742
Bucharest, Romania, 022328
Spitalul Clinic Judetean de Ur /ID# 96741
Cluj, Romania, 400006
Inst Oncology Prof. Chiricuta /ID# 96740
Cluj, Romania, 400010
Sc Oncolab Srl /Id# 96745
Craiova, Romania, 200385
Russian Federation
NN Blokhin Russian Cancer /ID# 65263
Moscow, Moskva, Russian Federation, 115478
Chelyabinsk Reg Clin Oncology /ID# 63938
Chelyabinsk, Russian Federation, 454087
Murmansk RCH P.A. Bayandina /ID# 102415
Murmansk, Russian Federation, 183047
City Clinical Hospital 1 /ID# 102416
Novosibirsk, Russian Federation, 630075
Pyatigorsk Oncology Dispensary /ID# 65264
Pyatigorsk, Russian Federation, 357502
Birch A Healthcare /ID# 65265
St. Petersburg, Russian Federation, 197183
N.N. Petrov Research Inst Onc /ID# 65269
St. Petersburg, Russian Federation, 197758
N.N. Petrov Research Inst Onc /ID# 78973
St. Petersburg, Russian Federation, 197758
Volgograd Reg Onc Disp #3 /ID# 98035
Volzhsky, Russian Federation, 404130
Spain
Hosp Santa Creu i Sant Pau /ID# 97418
Barcelona, Spain, 08026
Hospital Univ Vall d'Hebron /ID# 97415
Barcelona, Spain, 08035
Hospital General Universitario Gregorio Maranon /ID# 97417
Madrid, Spain, 28009
Hosp Univ Madrid Sanchinarro /ID# 97416
Madrid, Spain, 28050
Hosp Uni Virgen de la Victoria /ID# 97976
Malaga, Spain, 29010
Hosp Clin Univ de Valencia /ID# 97975
Valencia, Spain, 46010
Sweden
Skanes Universitetssjukhus /ID# 96475
Malmö, Skane Lan, Sweden, 214 28
Sahlgrenska University Hosp /ID# 97715
Goteborg, Sweden, 413 45
Karolinska Univ Sjukhuset /ID# 98037
Solna, Sweden, 17176
Ukraine
Cherkassy Regional Onc Ctr /ID# 97698
Cherkasy, Ukraine, 18000
City Multi-Field Clin Hosp #4 /ID# 63940
Dnipropetrovsk, Ukraine, 49102
Kharkiv Regional Clinical Onco /ID# 97696
Kharkiv, Ukraine, 61070
Lviv State Onc Local Treatment /ID# 63941
Lviv, Ukraine, 79031
Odessa National Medical Univ /ID# 65278
Odesa, Ukraine, 65026
Poltava Regional Clinical Onco /ID# 97697
Poltava, Ukraine, 36011
Sumy Reg Clinical Oncology Ctr /ID# 65280
Sumy, Ukraine, 40005
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01506609     History of Changes
Other Study ID Numbers: M12-895
2011-002913-12 ( EudraCT Number )
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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