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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
BRCA1 Mutation Carrier, BRCA2 Mutation Carrier, Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Primary Peritoneal Cavity Cancer

Thank you

Trial Information

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.


Inclusion Criteria:



- Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2
(confirmation required via Myriad test report); histologic documentation of the
original primary tumor is required via the pathology report

- All patients must have measurable disease as defined by Response Evaluation Criteria
in Solid Tumors(RECIST); 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 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 with both platinum-sensitive and platinum-resistant disease are eligible

- Platinum-sensitive ovarian cancer is defined as patients who respond to
platinum-based therapy (complete [CR]or partial response [PR]) 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 (CR or PR) and then progress/recur within 6 months of
their last platinum dose (i.e., platinum-free interval is ≤ 6 months)

- No patients with platinum-refractory disease

- 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 PR to platinum-based chemotherapy (i.e., best
response to platinum-based chemotherapy is stable disease)

- No patients with history or evidence upon physical examination of central nervous
system (CNS) disease, including primary brain tumor, seizures not controlled with
standard medical therapy, or any brain metastases

- Patients who have received one prior cytotoxic regimen must have a Gynecologic
Oncology Group (GOG) Performance Status of 0, 1, or 2; patients who have received two
or three prior regimens must have a GOG Performance Status of 0 or 1

- Patients should be free of active infection requiring antibiotics (with the exception
of uncomplicated urinaty tract infection [UTI])

- 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 times institutional upper limit of normal (ULN)

- Bilirubin less than or equal to 1.5 times ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
equal to 3 times ULN

- Alkaline phosphatase less than or equal to 2.5 times 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

- 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

- No ability or unwillingness to swallow pills

- No patients with clinical symptoms or signs of gastrointestinal obstruction and/or
who require parenteral hydration or nutrition

- No patients who are pregnant or nursing

- Patients with seizures or history or seizures are ineligible

- Patients with history or evidence upon physical examination of 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

- See Disease Characteristics

- Recovered from effects of recent surgery, radiotherapy, or chemotherapy

- 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 the initiation of study
treatment

- Any prior radiation therapy must be discontinued at least four weeks prior to
registration

- 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

- No patients who have had previous treatment with veliparib (ABT-888) or any other
poly (ADP-ribose) polymerase (PARP) inhibitor (including olaparib)

- Iniparib (BSI-201) cannot inhibit PARP1 at pharmacologically achievable
concentrations, therefore prior iniparib therapy is allowed

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The frequency of patients who have objective tumor response

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Robert Coleman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gynecologic Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-00684

NCT ID:

NCT01540565

Start Date:

April 2012

Completion Date:

Related Keywords:

  • brca1 Mutation Carrier
  • brca2 Mutation Carrier
  • Recurrent Fallopian Tube Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Primary Peritoneal Cavity Cancer
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Ovarian Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
Washington University School of MedicineSaint Louis, Missouri  63110
Abington Memorial HospitalAbington, Pennsylvania  19001
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
Via Christi Regional Medical CenterWichita, Kansas  67214
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Group Health CooperativeSeattle, Washington  98112
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Beebe Medical CenterLewes, Delaware  19958
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Mercy HospitalCoon Rapids, Minnesota  55433
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Seattle Cancer Care AllianceSeattle, Washington  98109
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Pacific Gynecology SpecialistsSeattle, Washington  98104
Memorial Medical CenterSpringfield, Illinois  62781
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
Hennepin County Medical CenterMinneapolis, Minnesota  
Case Western Reserve UniversityCleveland, Ohio  44106
Yale UniversityNew Haven, Connecticut  06520
Riverside Methodist HospitalColumbus, Ohio  43214
Wichita CCOPWichita, Kansas  67214-3882
Northwest HospitalSeattle, Washington  98133
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
Lakeview HospitalStillwater, Minnesota  55082
Decatur Memorial HospitalDecatur, Illinois  62526
Lankenau HospitalWynnewood, Pennsylvania  19096
Florida HospitalOrlando, Florida  32803
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
Harrison Medical CenterBremerton, Washington  98310
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030
New Ulm Medical CenterNew Ulm, Minnesota  56073
Northside HospitalAtlanta, Georgia  30342
University of California San Francisco Medical Center-Mount ZionSan Francisco, California  94115
The Hospital of Central ConnecticutNew Britain, Connecticut  06050
McFarland ClinicAmes, Iowa  50010
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Cooper Hospital University Medical CenterCamden, New Jersey  08103
New York University Langone Medical CenterNew York, New York  10016
Mainline Health CCOPWynnewood, Pennsylvania  19096
Greenville CCOPGreenville, South Carolina  29615
Upstate Carolina CCOPSpartanburg, South Carolina  29303
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Saint Joseph Medical CenterTacoma, Washington  98405
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Marshfield Clinic-Minocqua CenterMinocqua, Wisconsin  54548
Marshfield Clinic at James Beck Cancer CenterRhinelander, Wisconsin  54501
Marshfield Clinic-Rice Lake CenterRice Lake, Wisconsin  54868
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Cancer Care Associates-YaleTulsa, Oklahoma  74136-1929
Women and Infants HospitalProvidence, Rhode Island  02905
Lake University Ireland Cancer CenterMentor, Ohio  44060
John Muir Medical Center-Concord CampusConcord, California  94520
Moores University of California San Diego Cancer CenterLA Jolla, California  92093
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
Cancer Centers of the Carolinas - FarisGreenville, South Carolina  29605
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
Marshfield Clinic Cancer Care at Saint Michael's HospitalStevens Point, Wisconsin  54481
Hawaii Minority Based CCOPHonolulu, Hawaii  96813
Maine Medical Center-Bramhall CampusPortland, Maine  04102
Hope, A Women's Cancer CenterAsheville, North Carolina  28816
Aurora Women's Pavilion of Aurora West Allis Medical CenterWest Allis, Wisconsin  53227
Rocky Mountain Gynecologic Oncology PCEnglewood, Colorado  80110
Norton Health Care Pavilion - DowntownLouisville, Kentucky  40202
Women's Cancer Center of NevadaLas Vegas, Nevada  89109
Saint Francis HospitalGreenville, South Carolina  29601
Providence Regional Cancer PartnershipEverett, Washington  98201
Stanford University Hospitals and ClinicsStanford, California  94305
Gynecologic Oncology Group of ArizonaPhoenix, Arizona  85012
Sudarshan K Sharma MD Limted-Gynecologic OncologyHinsdale, Illinois  60521
Saint Vincent Oncology CenterIndianapolis, Indiana  46260
PeaceHealth Medical Group PCBellingham, Washington  98226
Skagit Valley Hospital Regional Cancer Care CenterMount Vernon, Washington  98274
Olympic Medical Cancer Care CenterSequim, Washington  98384
Rockwood Cancer Treatment CenterSpokane, Washington  99204
Providence Saint Mary Regional Cancer CenterWalla Walla, Washington  99362
Aurora Saint Luke's Medical CenterMilwaukee, Wisconsin  53215
Summa Akron City HospitalAkron, Ohio  44304
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Cleveland Clinic Cancer Center/Fairview HospitalCleveland, Ohio  44111
Saint Joseph's Hospital and Medical CenterPhoenix, Arizona  85013
Fletcher Allen Health Care-Medical CenterBurlington, Vermont  05401
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
Baylor All Saints Medical Center at Fort WorthFort Worth, Texas  76104
Gynecologic Oncology Associates-Newport BeachNewport Beach, California  92663