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.
Verified April 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01506609
First received: January 6, 2012
Last updated: April 4, 2013
Last verified: April 2013
  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: May 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:

  • 18 years of age, male and female.
  • 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
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: Anglea M. Deluca, BS (847) 936-3354 angela.deluca@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, 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# 60743 Recruiting
Los Angeles, California, United States, 90025
Principal Investigator: Site Reference ID/Investigator# 60743            
Site Reference ID/Investigator# 60760 Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Site Reference ID/Investigator# 60760            
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, Illinois
Site Reference ID/Investigator# 65489 Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Site Reference ID/Investigator# 65489            
Site Reference ID/Investigator# 60755 Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Site Reference ID/Investigator# 60755            
Site Reference ID/Investigator# 60757 Recruiting
Chicago, Illinois, United States, 60637-1470
Principal Investigator: Site Reference ID/Investigator# 60757            
Site Reference ID/Investigator# 60744 Recruiting
Zion, Illinois, United States, 60099
Principal Investigator: Site Reference ID/Investigator# 60744            
United States, Maryland
Site Reference ID/Investigator# 60748 Recruiting
Baltimore, Maryland, United States, 21202
Principal Investigator: Site Reference ID/Investigator# 60748            
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# 92633 Recruiting
Baltimore, Maryland, United States, 21231
Principal Investigator: Site Reference ID/Investigator# 92633            
United States, Massachusetts
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            
United States, Missouri
Site Reference ID/Investigator# 62724 Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Site Reference ID/Investigator# 62724            
United States, New Jersey
Site Reference ID/Investigator# 62783 Recruiting
New Brunswick, New Jersey, United States, 08901
Principal Investigator: Site Reference ID/Investigator# 62783            
United States, New York
Site Reference ID/Investigator# 60756 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 60756            
Site Reference ID/Investigator# 63222 Recruiting
New York, New York, United States, 10021
Principal Investigator: Site Reference ID/Investigator# 63222            
Site Reference ID/Investigator# 87973 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 87973            
Site Reference ID/Investigator# 87993 Recruiting
New York, New York, United States, 10003
Principal Investigator: Site Reference ID/Investigator# 87993            
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, 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# 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# 65487 Recruiting
Memphis, Tennessee, United States, 38120
Principal Investigator: Site Reference ID/Investigator# 65487            
United States, Texas
Site Reference ID/Investigator# 60745 Recruiting
Dallas, Texas, United States, 75390-9063
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 Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Site Reference ID/Investigator# 62722            
Australia
Site Reference ID/Investigator# 63280 Recruiting
Adelaide, Australia, SA 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 Recruiting
Milton, Australia, 4064
Principal Investigator: Site Reference ID/Investigator# 63276            
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            
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
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            
France
Site Reference ID/Investigator# 63926 Recruiting
Paris Cedex 05, France, 75248
Principal Investigator: Site Reference ID/Investigator# 63926            
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# 63931 Recruiting
Jerusalem, Israel, 91120
Principal Investigator: Site Reference ID/Investigator# 63931            
Site Reference ID/Investigator# 63929 Recruiting
Petach Tikva, Israel, 49100
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
Principal Investigator: Site Reference ID/Investigator# 63932            
Site Reference ID/Investigator# 65181 Recruiting
Zerifin, Israel, 70300
Principal Investigator: Site Reference ID/Investigator# 65181            
Norway
Site Reference ID/Investigator# 67982 Recruiting
Bergen, Norway, N-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# 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            
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# 65264 Recruiting
Pyatigorsk, Russian Federation, 357502
Principal Investigator: Site Reference ID/Investigator# 65264            
Site Reference ID/Investigator# 65265 Recruiting
St. Petersburg, Russian Federation, 197022
Principal Investigator: Site Reference ID/Investigator# 65265            
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            
Slovakia
Site Reference ID/Investigator# 65274 Recruiting
Nitra, Slovakia, 94911
Principal Investigator: Site Reference ID/Investigator# 65274            
Ukraine
Site Reference ID/Investigator# 63940 Recruiting
Dnepropetrovsk, Ukraine, 49102
Principal Investigator: Site Reference ID/Investigator# 63940            
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# 65280 Recruiting
Sumy, Ukraine, 40005
Principal Investigator: Site Reference ID/Investigator# 65280            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stacie P. Shepherd, MD AbbVie
  More 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: April 4, 2013
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

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

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

ClinicalTrials.gov processed this record on May 19, 2013