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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression -Free Survival
Radiographic evaluation every 9 weeks, clinical evaluation every cycle
No
Stacie P. Shepherd, MD
Study Director
AbbVie
United States: Food and Drug Administration
M12-895
NCT01506609
January 2012
May 2015
Name | Location |
---|---|
Site Reference ID/Investigator# 62994 | Birmingham, Alabama 35294-3300 |
Site Reference ID/Investigator# 60754 | La Jolla, California 92093 |
Site Reference ID/Investigator# 60743 | Los Angeles, California 90025 |
Site Reference ID/Investigator# 60751 | Aurora, Colorado 80045 |
Site Reference ID/Investigator# 60749 | Boca Raton, Florida 33486 |
Site Reference ID/Investigator# 62995 | Fort Lauderdale, Florida 33308 |
Site Reference ID/Investigator# 60746 | Tampa, Florida 33612 |
Site Reference ID/Investigator# 60762 | West Palm Beach, Florida 33401 |
Site Reference ID/Investigator# 60757 | Chicago, Illinois 60637-1470 |
Site Reference ID/Investigator# 60744 | Zion, Illinois 60099 |
Site Reference ID/Investigator# 60748 | Baltimore, Maryland 21202 |
Site Reference ID/Investigator# 62724 | St. Louis, Missouri 63110 |
Site Reference ID/Investigator# 60756 | New York, New York 10003 |
Site Reference ID/Investigator# 60753 | Philadelphia, Pennsylvania 19104 |
Site Reference ID/Investigator# 60758 | Pittsburgh, Pennsylvania 15213 |
Site Reference ID/Investigator# 65487 | Memphis, Tennessee 38120 |
Site Reference ID/Investigator# 60742 | Houston, Texas 77030 |
Site Reference ID/Investigator# 62722 | Salt Lake City, Utah 84112 |
Site Reference ID/Investigator# 60750 | Little Rock, Arkansas 72205 |
Site Reference ID/Investigator# 60760 | Los Angeles, California 90048 |
Site Reference ID/Investigator# 65488 | Stanford, California 94305-5826 |
Site Reference ID/Investigator# 65489 | Chicago, Illinois 60612 |
Site Reference ID/Investigator# 60755 | Chicago, Illinois 60611 |
Site Reference ID/Investigator# 60759 | Baltimore, Maryland 21231 |
Site Reference ID/Investigator# 91213 | Baltimore, Maryland 21231 |
Site Reference ID/Investigator# 92633 | Baltimore, Maryland 21231 |
Site Reference ID/Investigator# 64582 | Boston, Massachusetts 02114 |
Site Reference ID/Investigator# 71193 | Lansing, Michigan 48912 |
Site Reference ID/Investigator# 62783 | New Brunswick, New Jersey 08901 |
Site Reference ID/Investigator# 63222 | New York, New York 10021 |
Site Reference ID/Investigator# 87973 | New York, New York 10003 |
Site Reference ID/Investigator# 87993 | New York, New York 10003 |
Site Reference ID/Investigator# 60747 | Durham, North Carolina 27710 |
Site Reference ID/Investigator# 62723 | Hershey, Pennsylvania 17033-0850 |
Site Reference ID/Investigator# 60752 | Charleston, South Carolina 29425 |
Site Reference ID/Investigator# 60745 | Dallas, Texas 75390-9063 |