Clinical trial NCT02470585: Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Ovarian Cancer
Ovarian Neoplasm
Keywords: Veliparib
Carboplatin
Paclitaxel
Overall Survival
ABT-888
Randomized
Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP)
Ovarian
BRCA
VELIA
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Australia New Zealand Gynaecological Oncology Group
First posted: 2015-06-12
Enrollment: 1140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel \[C/P\]) and continued as maintenance therapy compared with chemotherapy alone.

Detailed description: Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world \[ROW\]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown).

Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator.

The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.

Eligibility criteria: Inclusion Criteria:

1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
2. High-grade serous adenocarcinoma
3. Willing to undergo testing for gBRCA.
4. Adequate hematologic, renal, and hepatic function.
5. Neuropathy (sensory and motor) less than or equal to Grade 1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.
8. Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.
9. Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.

Exclusion Criteria:

1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.
3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.
4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.
5. Received prior chemotherapy for any abdominal or pelvic tumor.
6. Clinically significant uncontrolled condition(s).
7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD\&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD\&C Yellow 6 or E110) or known contraindications to any study supplied drug.
8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day 1.

Primary outcomes:
measure: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 3 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
measure: Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 3 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
measure: Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 3 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
Secondary outcomes:
measure: Progression-Free Survival (PFS) in the BRCA-deficient Population (Arm 2 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
measure: Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort (Arm 2 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
measure: Progression-Free Survival (PFS) in the Intention-to-treat Population (Arm 2 vs Arm 1)
timeFrame: From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.
measure: Overall Survival (OS) in the BRCA-deficient Population
timeFrame: From the time of randomization to the end of the study, up to 98 months
measure: Overall Survival (OS) in the Homologous Recombination Deficiency Population
timeFrame: From the time of randomization to the end of the study, up to 98 months
measure: Overall Survival (OS) in the Whole Population
timeFrame: From the time of randomization to the end of the study, up to 98 months
measure: Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
measure: Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
measure: Change From Baseline in Disease Related Symptom (DRS) Score in the Whole Population
timeFrame: Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 138087
state: Alabama
city: Huntsville
country: United States
facility: Tennessee Valley Gyn-Onc /ID# 139548
state: Alabama
city: Mobile
country: United States
facility: University of South Alabama /ID# 138091
state: Alabama
city: Anchorage
country: United States
facility: Alaska Womens Cancer Care /ID# 138231
state: Alaska
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE /ID# 142002
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE /ID# 143805
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE /ID# 143806
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC-HOPE /ID# 143808
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 138084
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center - North Campus /ID# 139495
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences /ID# 138253
state: Arkansas
city: Concord
country: United States
facility: John Muir Medical Center /ID# 139618
state: California
city: La Jolla
country: United States
facility: Ucsd /Id# 140323
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Ct /ID# 147526
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente /ID# 141305
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles /ID# 138179
state: California
city: Orange
country: United States
facility: Medical Oncology Care Assoc /ID# 139498
state: California
city: Orange
country: United States
facility: Univ CA, Irvine Med Ctr /ID# 139613
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center - Main /ID# 144439
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Ctr /ID# 138177
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco /ID# 142051
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 138178
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente-Santa Clara /ID# 142053
state: California
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 139450
state: California
city: Sunnyvale
country: United States
facility: Palo Alto Medical Foundation /ID# 139452
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente Medical Ctr-Vallejo /ID# 139492
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente- Walnut Creek /ID# 142052
state: California
city: Aurora
country: United States
facility: Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499
state: Colorado
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 138016
state: Colorado
city: New Britain
country: United States
facility: Hartford Healthcare /ID# 138184
state: Connecticut
city: New Haven
country: United States
facility: Yale University /ID# 138056
state: Connecticut
city: Miami
country: United States
facility: University of Miami /ID# 139457
state: Florida
city: Saint Petersburg
country: United States
facility: Women's Cancer Associates /ID# 140321
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Health Care /ID# 138180
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center /ID# 138061
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University /ID# 138085
state: Georgia
city: Columbus
country: United States
facility: IACT Health /ID# 138058
state: Georgia
city: Savannah
country: United States
facility: Memorial Health Univ Med Ctr /ID# 138019
state: Georgia
city: Savannah
country: United States
facility: St. Joseph's/Candler /ID# 138090
state: Georgia
city: Honolulu
country: United States
facility: The Queens Medical Center /ID# 141709
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center /ID# 140319
state: Hawaii
city: Chicago
country: United States
facility: Rush University Medical Center /ID# 143491
state: Illinois
city: Chicago
country: United States
facility: University of Chicago /ID# 139612
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem - Evanston Hospital /ID# 139451
state: Illinois
city: Hinsdale
country: United States
facility: Sharma, Hinsdale, IL /ID# 140326
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hosp /ID# 139489
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ School Medicine /ID# 139610
state: Indiana
city: Indianapolis
country: United States
facility: Saint Vincent /ID# 139537
state: Indiana
city: Ames
country: United States
facility: McFarland Clinic, PC /ID# 139455
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics /ID# 138082
state: Iowa
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 140322
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington /ID# 139542
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 138060
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute /ID# 139567
state: Kentucky
city: Portland
country: United States
facility: MMP Women's Health /ID# 139544
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Ctr /ID# 138049
state: Maryland
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore /ID# 141306
state: Maryland
city: Rossville
country: United States
facility: Weinberg Cancer Inst Franklin /ID# 138235
state: Maryland
city: Springfield
country: United States
facility: Baystate Medical Center /ID# 139456
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center /ID# 139458
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University /ID# 139601
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 139536
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital /ID# 139550
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 139565
state: Minnesota
city: Saint Louis Park
country: United States
facility: Mmcorc /Id# 139534
state: Minnesota
city: Jackson
country: United States
facility: St. Dominic Hospital /ID# 138241
state: Mississippi
city: Columbia
country: United States
facility: Ellis Fischel Cancer Center /ID# 139571
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 138089
state: Missouri
city: Springfield
country: United States
facility: Cancer Research For the Ozarks /ID# 139538
state: Missouri
city: Springfield
country: United States
facility: Ferrell-Duncan Clinic /ID# 143484
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital /ID# 139600
state: Nebraska
city: Las Vegas
country: United States
facility: Womens Cancer Center of Nevada /ID# 138092
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center /ID# 138237
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 139502
state: New Hampshire
city: Camden
country: United States
facility: MD Anderson Cancer Ctr at Coop /ID# 139616
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack Univ Med Ctr /ID# 143776
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 144220
state: New Mexico
city: Albuquerque
country: United States
facility: SW Gynecologic Oncology Assoc /ID# 147097
state: New Mexico
city: Albany
country: United States
facility: Women's Cancer Care Associates /ID# 138234
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 139585
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center /ID# 139533
state: New York
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center /ID# 138052
state: New York
city: Lake Success
country: United States
facility: Northwell Health /ID# 139572
state: New York
city: New York
country: United States
facility: Icahn School of Med Mt. Sinai /ID# 139617
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 138252
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center /ID# 138017
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center /ID# 154464
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University - Downtown /ID# 139513
state: New York
city: Asheville
country: United States
facility: Hope Womens Cancer Centers /ID# 139614
state: North Carolina
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 138547
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center /ID# 139568
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Cancer Center /ID# 139590
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center /ID# 138048
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center /ID# 139588
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 139619
state: Ohio
city: Cleveland
country: United States
facility: Univ Hosp Cleveland /ID# 139615
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital /ID# 144403
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 139501
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University - Columbus /ID# 138053
state: Ohio
city: Columbus
country: United States
facility: Columbus NCORP /ID# 139587
state: Ohio
city: Kettering
country: United States
facility: Womens Cancer Center /ID# 138062
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital /ID# 144404
state: Ohio
city: Oklahoma City
country: United States
facility: Univ Oklahoma HSC /ID# 138020
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists /ID# 138059
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute /ID# 140318
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente, NW /ID# 138249
state: Oregon
city: Abington
country: United States
facility: Abington Memorial Hospital /ID# 138086
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 140079
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University /ID# 138239
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center /ID# 149479
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 138054
state: Pennsylvania
city: Reading
country: United States
facility: Reading Hospital /ID# 138057
state: Pennsylvania
city: Providence
country: United States
facility: Women and Infants Hospital /ID# 138083
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 138181
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research/USD /ID# 139624
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanoogas Program in Womens /ID# 139545
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology - Austin Central /ID# 143817
state: Texas
city: Austin
country: United States
facility: Texas Oncology - South Austin /ID# 143818
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford /ID# 143814
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 143809
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas /ID# 143812
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Forth Worth /ID# 143811
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital - Scurlock Tower /ID# 138232
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital /ID# 138238
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands /ID# 142003
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler /ID# 143810
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 138250
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center /ID# 138251
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia /ID# 138088
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hosp /ID# 139602
state: Virginia
city: Mount Vernon
country: United States
facility: Skagit Valley Medical Center /ID# 139586
state: Washington
city: Puyallup
country: United States
facility: MultiCare Regional Cancer Ctr /ID# 149872
state: Washington
city: Tacoma
country: United States
facility: Multicare Institute for Research and Innovation /ID# 143485
state: Washington
city: Green Bay
country: United States
facility: HSHS St. Vincent Hospital /ID# 139453
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin /ID# 139449
state: Wisconsin
city: Coffs Harbour
country: Australia
facility: Coffs Harbour Health Campus /ID# 145132
state: New South Wales
city: Gosford
country: Australia
facility: Gosford Hospital /ID# 145299
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital /ID# 145138
state: New South Wales
city: Lambton Heights
country: Australia
facility: Newcastle Private Hospital /ID# 145834
state: New South Wales
city: Randwick
country: Australia
facility: The Prince of Wales Hospital /ID# 145134
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute /ID# 145681
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle /ID# 145139
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 145137
state: New South Wales
city: Wollongong
country: Australia
facility: Southern Medical Day Care Ctr /ID# 145133
state: New South Wales
city: Douglas
country: Australia
facility: The Townsville Hospital /ID# 149163
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 145135
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Centre /ID# 148208
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited /ID# 145682
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 150071
state: South Australia
city: Clayton
country: Australia
facility: Monash Health /ID# 145297
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health /ID# 145142
state: Victoria
city: Parkville
country: Australia
facility: Royal Womens Hospital /ID# 145136
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital /ID# 145140
state: Western Australia
city: Subiaco
country: Australia
facility: St. John of God Subiaco Hosp /ID# 147742
state: Western Australia
city: Belo Horizonte
country: Brazil
facility: Hc Ufmg /Id# 137156
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS /ID# 137157
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos /ID# 137121
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155
city: Vejle
country: Denmark
facility: Vejle Sygehus /ID# 137262
state: Syddanmark
city: Herning
country: Denmark
facility: Regionshospitalet Herning /ID# 137260
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 137434
city: Haifa
country: Israel
facility: The Lady Davis Carmel MC /ID# 137537
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 137435
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 139397
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 137436
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 137536
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital /ID# 148398
state: Aichi
city: Fukuoka-shi
country: Japan
facility: National Hospital Organization Kyushu Cancer Center /ID# 149133
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 148697
state: Fukuoka
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital /ID# 147721
state: Iwate
city: Kumamoto-shi
country: Japan
facility: Kumamoto University Hospital /ID# 154169
state: Kumamoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 149169
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 149818
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 149488
state: Niigata
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital /ID# 154947
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center /ID# 147723
state: Shizuoka
city: Koto-ku
country: Japan
facility: The Cancer Institute Hosp JFCR /ID# 148436
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 148326
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Yamagata University Hospital /ID# 153646
state: Yamagata
city: Akashi
country: Japan
facility: Hyogo Cancer Center /ID# 148327
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital /ID# 149237
city: Kashiwa-shi
country: Japan
facility: The Jikei Univ. Kashiwa Hosp. /ID# 149238
city: Kawasaki
country: Japan
facility: St. Marianna Univ Hospital /ID# 149327
city: Kure
country: Japan
facility: NHO Kure Medical Center and Ch /ID# 148569
city: Matsuyama
country: Japan
facility: Shikoku Cancer Center /ID# 148382
city: Osaka
country: Japan
facility: Osaka International Cancer Institute /ID# 150778
city: Sapporo
country: Japan
facility: Hokkaido Cancer Center /ID# 148570
city: Tokyo
country: Japan
facility: The Jikei University Hospital /ID# 148691
city: Goyang
country: Korea, Republic of
facility: National Cancer Center /ID# 139404
state: Gyeonggido
city: 성북구
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 136908
state: Gyeonggido
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital /ID# 136835
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 136834
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 136909
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 136836
city: Auckland
country: New Zealand
facility: Auckland City Hospital /ID# 145123
city: Gdańsk
country: Poland
facility: Uniwersyteckie C. Kliniczne /ID# 138021
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals /ID# 137298
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron /ID# 137297
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 137300
city: Madrid
country: Spain
facility: Hospital Clin Univ San Carlos /ID# 137402
city: Madrid
country: Spain
facility: Hosp Univ 12 de Octubre /ID# 137299
city: Madrid
country: Spain
facility: Hosp Univ Madrid Sanchinarro /ID# 137414
city: Valencia
country: Spain
facility: Fundacion Inst Valenciano Onc /ID# 137403
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Univ Hosp /ID# 137969
state: Norfolk
city: Glasgow
country: United Kingdom
facility: Beatson west of scotland cancer center /ID# 137965
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital /ID# 137967
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hosp /ID# 137970
city: London
country: United Kingdom
facility: Imanova Limited, Hammersmith Hospital /ID# 137966
city: Oxford
country: United Kingdom
facility: Oxford Univ Hosp NHS Trust /ID# 137973
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
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citation: Swisher EM, Aghajanian C, O'Malley DM, Fleming GF, Kaufmann SH, Levine DA, Birrer MJ, Moore KN, Spirtos NM, Shahin MS, Reid TJ, Friedlander M, Steffensen KD, Okamoto A, Sehgal V, Ansell PJ, Dinh MH, Bookman MA, Coleman RL. Impact of homologous recombination status and responses with veliparib combined with first-line chemotherapy in ovarian cancer in the Phase 3 VELIA/GOG-3005 study. Gynecol Oncol. 2022 Feb;164(2):245-253. doi: 10.1016/j.ygyno.2021.12.003. Epub 2021 Dec 11.
citation: Washington CR, Moore KN. PARP inhibitors in the treatment of ovarian cancer: a review. Curr Opin Obstet Gynecol. 2021 Feb 1;33(1):1-6. doi: 10.1097/GCO.0000000000000675.
citation: Nishikawa T, Matsumoto K, Tamura K, Yoshida H, Imai Y, Miyasaka A, Onoe T, Yamaguchi S, Shimizu C, Yonemori K, Shimoi T, Yunokawa M, Xiong H, Nuthalapati S, Hashiba H, Kiriyama T, Leahy T, Komarnitsky P, Fujiwara K. Phase 1 dose-escalation study of single-agent veliparib in Japanese patients with advanced solid tumors. Cancer Sci. 2017 Sep;108(9):1834-1842. doi: 10.1111/cas.13307. Epub 2017 Aug 5.