A PHASE II EVALUATION OF THE POLY (ADP-RIBOSE) POLYMERASE (PARP) -1 AND -2 INHIBITOR VELIPARIB (ABT-888) (IND #77840) (NSC #737664) IN THE TREATMENT OF PERSISTENT OR RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER PATIENTS WHO CARRY A GERMLINE BRCA1 OR BRCA2 MUTATION
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients who have objective tumor response (complete or
partial).
II. To determine the frequency and severity of adverse events associated with treatment with
veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE).
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival (PFS) and overall survival (OS).
II. To determine the proportion of patients who survive progression-free for at least 6
months.
TERTIARY OBJECTIVES:
I. To explore the association between single nucleotide polymorphisms (SNPs) in DNA repair
genes (e.g., BRCA1, Fanconi) and clinical characteristics, response, and patient outcome
(PFS and OS).
OUTLINE: This is a multicenter study.
Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.
Patients may undergo blood and tumor tissue sample collection for single nucleotide
polymorphisms in DNA analysis.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The frequency of patients who have objective tumor response
Up to 5 years
No
Robert Coleman
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2012-00684
NCT01540565
April 2012
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Group Health Cooperative | Seattle, Washington 98112 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Beebe Medical Center | Lewes, Delaware 19958 |
Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Rutherford Hospital | Rutherfordton, North Carolina 28139 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
Memorial Medical Center | Springfield, Illinois 62781 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Case Western Reserve University | Cleveland, Ohio 44106 |
Yale University | New Haven, Connecticut 06520 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Northwest Hospital | Seattle, Washington 98133 |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
Florida Hospital | Orlando, Florida 32803 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
Harrison Medical Center | Bremerton, Washington 98310 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
New Ulm Medical Center | New Ulm, Minnesota 56073 |
Northside Hospital | Atlanta, Georgia 30342 |
University of California San Francisco Medical Center-Mount Zion | San Francisco, California 94115 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
McFarland Clinic | Ames, Iowa 50010 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
New York University Langone Medical Center | New York, New York 10016 |
Mainline Health CCOP | Wynnewood, Pennsylvania 19096 |
Greenville CCOP | Greenville, South Carolina 29615 |
Upstate Carolina CCOP | Spartanburg, South Carolina 29303 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
John Muir Medical Center-Concord Campus | Concord, California 94520 |
Moores University of California San Diego Cancer Center | LA Jolla, California 92093 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Hawaii Minority Based CCOP | Honolulu, Hawaii 96813 |
Maine Medical Center-Bramhall Campus | Portland, Maine 04102 |
Hope, A Women's Cancer Center | Asheville, North Carolina 28816 |
Aurora Women's Pavilion of Aurora West Allis Medical Center | West Allis, Wisconsin 53227 |
Rocky Mountain Gynecologic Oncology PC | Englewood, Colorado 80110 |
Norton Health Care Pavilion - Downtown | Louisville, Kentucky 40202 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Saint Francis Hospital | Greenville, South Carolina 29601 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Stanford University Hospitals and Clinics | Stanford, California 94305 |
Gynecologic Oncology Group of Arizona | Phoenix, Arizona 85012 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
PeaceHealth Medical Group PC | Bellingham, Washington 98226 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Olympic Medical Cancer Care Center | Sequim, Washington 98384 |
Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Saint Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
Fletcher Allen Health Care-Medical Center | Burlington, Vermont 05401 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Baylor All Saints Medical Center at Fort Worth | Fort Worth, Texas 76104 |
Gynecologic Oncology Associates-Newport Beach | Newport Beach, California 92663 |