Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT ID: NCT01540565
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2012-04-09
2018-01-27
Brief Summary
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Detailed Description
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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) version 4.0
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 deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer \[BRCA\]1, Fanconi) and clinical characteristics, response, and patient outcome (PFS and OS).
OUTLINE:
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.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (veliparib)
Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis
Correlative studies
Veliparib
Given PO
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Veliparib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors(RECIST)1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be \>= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or \>= 20 mm when measured by chest x-ray; lymph nodes must be \>= 15 mm in short axis when measured by CT or MRI
* Patient must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST; tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
* Patients who have received one prior cytotoxic regimen must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
* Patients who have received two or three prior cytotoxic regimens must have a GOG performance status of 0 or 1
* Recovery from effects of recent surgery, radiotherapy, or chemotherapy
* Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection \[UTI\])
* Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration; continuation of hormone replacement therapy is permitted
* Any other prior therapy directed at the malignant tumor, including chemotherapy, biologic/targeted (non-cytotoxic) agents and immunologic agents, must be discontinued at least three weeks prior to registration; patients receiving nitrosoureas or mitomycin C must discontinue 6 weeks prior to registration
* Any prior radiation therapy must be discontinued at least four weeks prior to registration
* Prior therapy
* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended therapy administered after surgical or non-surgical assessment
* Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease
* Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy for management of recurrent or persistent disease; patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary treatment regimen
* Patients with both platinum-sensitive and platinum-resistant disease are eligible; patients with platinum-refractory disease are NOT eligible
* Definitions:
* Platinum sensitive ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur more than 6 months after their last platinum dose (i.e., platinum-free interval is \> 6 months)
* Platinum resistant ovarian cancer is defined as patients who respond to platinum-based therapy (complete or partial) and then progress/recur within 6 months of their last platinum dose (i.e., platinum-free interval is =\< 6 months)
* Platinum refractory ovarian cancer is defined as patients who have progression of disease while receiving platinum-based chemotherapy or who fail to achieve at least a partial response to platinum-based chemotherapy (i.e., best response to platinum-based chemotherapy is stable disease)
* Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl
* Platelets greater than or equal to 100,000/mcl
* Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)
* Bilirubin less than or equal to 1.5 x ULN
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x ULN
* Alkaline phosphatase less than or equal to 2.5 x ULN
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
* Patients of childbearing potential must have a negative pregnancy test prior to the study entry and be practicing an effective form of contraception
Exclusion Criteria
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
* Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease
* Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last three years are excluded; patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease
* Patients with seizures or history or seizures are ineligible
* Patients with history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any CNS metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study are ineligible; patients with CNS metastases must be stable for \> 3 months after treatment and off steroid treatment prior to study enrollment
* Inability or unwillingness to swallow pills
* Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who require parenteral hydration or nutrition
* Patients who are pregnant or nursing
18 Years
FEMALE
No
Sponsors
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NRG Oncology
OTHER
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Robert Coleman
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
John Muir Medical Center-Concord Campus
Concord, California, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Gynecologic Oncology Associates-Newport Beach
Newport Beach, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States
UCSF Medical Center-Mount Zion
San Francisco, California, United States
Rocky Mountain Gynecologic Oncology PC
Englewood, Colorado, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Florida Hospital Orlando
Orlando, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center-Gainesville
Gainesville, Georgia, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Norton Hospital Pavilion and Medical Campus
Louisville, Kentucky, United States
Maine Medical Center-Bramhall Campus
Portland, Maine, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Union Hospital of Cecil County
Elkton, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Hope Women's Cancer Centers-Asheville
Asheville, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Southeast Clinical Oncology Research (SCOR) Consortium NCORP
Winston-Salem, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States
Lake University Ireland Cancer Center
Mentor, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, United States
Women and Infants Hospital
Providence, Rhode Island, United States
AnMed Health Cancer Center
Anderson, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Baylor All Saints Medical Center at Fort Worth
Fort Worth, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
PeaceHealth Medical Group PC
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Harrison Medical Center
Bremerton, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Skagit Valley Hospital Regional Cancer Care Center
Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Pacific Gynecology Specialists
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
Northwest Hospital
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Olympic Medical Cancer Care Center
Sequim, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Rockwood Cancer Treatment Center-DHEC-Downtown
Spokane, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2012-00684
Identifier Type: REGISTRY
Identifier Source: secondary_id
S12-02446
Identifier Type: -
Identifier Source: secondary_id
GOG-0280
Identifier Type: -
Identifier Source: secondary_id
CDR0000726699
Identifier Type: -
Identifier Source: secondary_id
GOG-0280
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0280
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-00684
Identifier Type: -
Identifier Source: org_study_id
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