Lung Cancer Clinical Trial

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Summary

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Life expectancy > 12 weeks
Subject must have cytologically or histologically confirmed squamous NSCLC.
Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
Subject has a known hypersensitivity to platinum compounds.
Subject has peripheral neuropathy >= grade 2.
Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT02106546

Recruitment Status:

Completed

Sponsor:

AbbVie

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There are 218 Locations for this study

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Northeast Arkansas Clinical Ch /ID# 128071
Jonesboro Arkansas, 72401, United States
LA Hem-Oncology Med Group /ID# 129178
Los Angeles California, 90017, United States
VA Eastern Colorado Healthcare System /ID# 128065
Aurora Colorado, 80045, United States
Holy Cross Hospital /ID# 128074
Fort Lauderdale Florida, 33308, United States
University of Florida - Archer /ID# 126476
Gainesville Florida, 32610, United States
Cancer Specialists of North Florida - Southpoint /ID# 127815
Jacksonville Florida, 32256, United States
Winship Cancer Institute of Emory University /ID# 124061
Atlanta Georgia, 30322, United States
St. Luke's Mountain States Tumor Institute - Boise /ID# 124059
Boise Idaho, 83712, United States
Illinois Cancer Specialists /ID# 127468
Arlington Heights Illinois, 60005, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 128585
Evanston Illinois, 60201, United States
Ingalls Memorial Hosp /ID# 128360
Harvey Illinois, 60426, United States
Midwestern Regional CTC /ID# 126124
Zion Illinois, 60099, United States
Goshen Center for Cancer Care /ID# 123875
Goshen Indiana, 46526, United States
Franciscan St. Francis Health /ID# 126678
Indianapolis Indiana, 46237, United States
Appalachian Regional Healthcare, Inc (ARH) /ID# 128061
Hazard Kentucky, 41701, United States
Henry Ford Health System /ID# 126500
Detroit Michigan, 48202, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 127156
Lansing Michigan, 48912, United States
Minnesota Oncology Hematology, PA /ID# 127473
Minneapolis Minnesota, 55404, United States
Nebraska Hematology Oncology /ID# 127699
Lincoln Nebraska, 68506, United States
SE Nebraska Hema/Oncology Consultants P.C.d/b/a Southeast Nebraska Cancer Center /ID# 126477
Lincoln Nebraska, 68510, United States
Comprehensive Cancer Ctrs Neva /ID# 127491
Las Vegas Nevada, 89169, United States
Dartmouth-Hitchcock Medical Center /ID# 128075
Lebanon New Hampshire, 03756, United States
Hackensack Univ Med Ctr /ID# 124057
Hackensack New Jersey, 07601, United States
Gabrail Cancer Center Research /ID# 127415
Canton Ohio, 44718, United States
Penn State University and Milton S. Hershey Medical Center /ID# 126676
Hershey Pennsylvania, 17033, United States
The Jones Clinic, PC /ID# 124062
Germantown Tennessee, 38138, United States
Texas Oncology - Austin Midtown /ID# 127477
Austin Texas, 78705, United States
Texas Oncology - South Austin /ID# 127476
Austin Texas, 78745, United States
Parkland Health and Hosp Syste /ID# 128518
Dallas Texas, 75235, United States
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 128385
Dallas Texas, 75246, United States
UT Southwestern Medical Center /ID# 127876
Dallas Texas, 75390, United States
University of Texas MD Anderson Cancer Center /ID# 127946
Houston Texas, 77030, United States
Texas Oncology - Paris /ID# 127484
Paris Texas, 75460, United States
Texas Oncology - Waco /ID# 127459
Waco Texas, 76712, United States
University of Vermont Medical Center /ID# 128064
Burlington Vermont, 05401, United States
Virginia Oncology Associates /ID# 127458
Norfolk Virginia, 23502, United States
Northwest Cancer Specialists, P.C. /ID# 127486
Vancouver Washington, 98684, United States
Northwest Cancer Specialists, P.C. /ID# 127488
Vancouver Washington, 98684, United States
Southern Medical Day Care Ctr /ID# 125604
Wollongong New South Wales, 2500, Australia
Sunshine Coast University Hosp /ID# 125608
Birtinya Queensland, 4575, Australia
The Townsville Hospital /ID# 125609
Douglas Queensland, 4814, Australia
Flinders Centre for Innovation /ID# 125605
Bedford Park South Australia, 5042, Australia
The Queen Elizabeth Hospital /ID# 125607
Woodville South Australia, 5011, Australia
Barwon Health University Hospital Geelong /ID# 125606
Geelong Victoria, 3220, Australia
Ordensklinikum Linz GmbH, Elisabethinen /ID# 126183
Linz , 4020, Austria
Bobruysk Interdistrict Onco. /ID# 128999
Bobruisk , 21382, Belarus
Brest Regional Hospital /ID# 125955
Brest , 22402, Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 125815
Lesnoy , 22304, Belarus
Mogilev Reg Clin Oncology Dis /ID# 128639
Mogilev , 21201, Belarus
Vitebsk Reg Clin Onc Disp /ID# 125516
Vitebsk , 21060, Belarus
Hospital Sao Lucas da PUCRS /ID# 127737
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai /ID# 127738
Itajai Santa Catarina, 88301, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 126736
Barretos Sao Paulo, 14784, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 127309
Rio de Janeiro , 20231, Brazil
Instituto COI de Educacao e Pesquisa /ID# 127739
Rio de Janeiro , 22793, Brazil
Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 126737
Sao Paulo , 01509, Brazil
University of Calgary /Id# 126326
Calgary Alberta, T2N 4, Canada
Cross Cancer Institute /ID# 126154
Edmonton Alberta, T6G 1, Canada
Juravinski Cancer Clinic /ID# 126153
Hamilton Ontario, L8V 1, Canada
Victoria Hospital /ID# 126669
London Ontario, N6A 4, Canada
The Ottawa Hospital /ID# 126522
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre /ID# 126155
Toronto Ontario, M5G 2, Canada
McGill Univ HC /ID# 130431
Montreal Quebec, H3G 1, Canada
CSSS Alphonse-Desjardins, CHAU de Levis /ID# 126149
Quebec City Quebec, G6V 3, Canada
Iucpq-Ul /Id# 126524
Québec Quebec, G1V 4, Canada
Klinika za plucne bolesti Jordanovac /ID# 126537
Zagreb Grad Zagreb, 10000, Croatia
Klinicki bolnicki centar Osijek /ID# 132214
Osijek Osjecko-baranjska Zupanija, 31000, Croatia
Opca bolnica Pula /ID# 126540
Pula , 52100, Croatia
Opca bolnica Dr. Josip Bencevi /ID# 126539
Slavonski Brod , 35000, Croatia
Fakultni Nemocnice Olomouc /ID# 125820
Olomouc Olomoucky Kraj, 779 0, Czechia
Nemocnice Na Plesi s.r.o. /ID# 125817
Nová Ves pod Pleší Pribram, 262 0, Czechia
Nemocnice Kyjov, prispevkova organizace /ID# 125819
Kyjov , 697 0, Czechia
Nemocnice Novy Jicin /ID# 125818
Nový Jičín 1 , 741 0, Czechia
Vitkovicka nemocnice a. s. /ID# 127023
Ostrava , 703 8, Czechia
Herlev Hospital /ID# 125995
Herlev Hovedstaden, 2730, Denmark
Odense Universitets Hospital /ID# 125996
Odense C Syddanmark, 5000, Denmark
University of Alexandria /ID# 128337
Alexandria , 21131, Egypt
Naser Institute for Res & Dev /ID# 129263
Cairo , 11511, Egypt
Cairo Uni Hosp Al Kasr El Ainy /ID# 128338
Cairo , 11956, Egypt
Cairo Uni Hosp Al Kasr El Ainy /ID# 128340
Cairo , 11956, Egypt
North Estonian Medical Centre /ID# 128215
Tallinn , 13419, Estonia
Tartu University Hospital /ID# 127735
Tartu , 51014, Estonia
Helsinki Univ Central Hospital /ID# 125897
Helsinki , 00290, Finland
Vaasa Central Hospital /ID# 125896
Vaasa , 65130, Finland
CHU Hopital Nord /ID# 128388
Marseille Bouches-du-Rhone, 13915, France
Hopital Haut-Lévêque /ID# 135270
Pessac CEDEX Gironde, 33604, France
CHRU Lille - Hôpital Claude Huriez /ID# 126353
Lille CEDEX Hauts-de-France, 59045, France
Centre Hospitalier Le Mans /ID# 127902
Le Mans CEDEX 9 Sarthe, 72037, France
Centre Hosp Intercommunal de Creteil /ID# 125922
Creteil Val-de-Marne, 94000, France
CHRU de Brest - Hopital Morvan /ID# 127903
Brest , 29200, France
Centre Antoine Lacassagne /ID# 126360
Nice , 06189, France
Hospital Pontchaillou /ID# 126356
Rennes , 35033, France
Hopital Larrey - CHU de Toulouse /ID# 128394
Toulouse , 31059, France
Charite-Univ. Berlin, Benjamin-Franklin /ID# 125708
Berlin , 12203, Germany
Lungen Clinic Grosshansdorf /ID# 126107
Grosshansdorf , 22927, Germany
Klinikum Kassel /ID# 127025
Kassel , 34125, Germany
Klinik Loewenstein GmbH /ID# 126191
Löwenstein , 74245, Germany
Univ Johannes Gutenberg /ID# 125603
Mainz , 55131, Germany
Papageorgiou General Hospital Thessaloniki /ID# 125876
Nea Efkarpia Thessaloniki, 54603, Greece
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 125879
Athens , 11527, Greece
Metropolitan Hospital /ID# 125878
Athens , 18547, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 125877
Heraklion , 71110, Greece
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 135234
Miskolc Borsod-Abauj-Zemplen, 3529, Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 126112
Budapest XII Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Központ /ID# 126119
Debrecen , 4032, Hungary
Veszprem Megyei Tudogyogyintez /ID# 126121
Farkasgyepu , 8582, Hungary
Petz Aladar Megyei Oktato Korh /ID# 126110
Gyor , 9023, Hungary
Bekes Megyei Pandy Kalman Korhaz /ID# 126117
Gyula , 5700, Hungary
Matrahaza Gyogyintezet /ID# 126109
Kékesteto , 3233, Hungary
Fejer Megyei Szent Gyorgy Korh /ID# 126118
Szekesfehervar , 8000, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz /ID# 126120
Szolnok , 5004, Hungary
Tudogyogyintezet Toeroekbalint /ID# 126111
Torokbalint , 2045, Hungary
St. James's Hospital /ID# 126177
Dublin 8 Dublin, D08 E, Ireland
Cork University Hospital /ID# 126176
Cork , T12 E, Ireland
Beaumont Hospital /ID# 126218
Dublin , D09 X, Ireland
University Hospital Limerick /ID# 126175
Limerick , V94F8, Ireland
University Hospital Waterford /ID# 126178
Waterford , X91 E, Ireland
Assaf Harofeh Medical Center /ID# 127076
Be'er Ya'akov , 70300, Israel
Hadassah University Hospital /ID# 127077
Jerusalem , 91120, Israel
Meir Medical Center /ID# 127078
Kfar Saba , 44281, Israel
Sheba Medical Center /ID# 127079
Ramat Gan , 52394, Israel
AO San Giuseppe Moscati /ID# 125701
Avellino , 83100, Italy
Istituto Europeo di Oncologia /ID# 125702
Milan , 20141, Italy
Azienda Ospedaliera San Gerardo di Monza _ Oncologia Medica /ID# 125704
Monza , 20052, Italy
A.O.U. San Luigi Gonzaga /ID# 125700
Orbassano , 10043, Italy
Azienda Ospedaliero Uni Parma /ID# 125703
Parma , 43100, Italy
Azienda Ospedaliera-Universitaria di Perugia-Divisione di Oncologia Medica. /ID# 125699
Perugia , 06100, Italy
Istituto Oncologico del Medite /ID# 132844
Viagrande , 95029, Italy
Riga East Clinical Univ Hosp /ID# 125597
Riga , 1038, Latvia
P. Stradins Clinical Univ Hosp /ID# 126322
Riga , LV-10, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 127176
Kovno Kaunas, 50009, Lithuania
National Cancer Institute /ID# 126323
Vilnius , 08660, Lithuania
Centro Estatal de Cancerologia /ID# 127583
Chihuahua , 31000, Mexico
Hospital Angeles Centro Medico /ID# 127620
San Luis Potosí , 78216, Mexico
Cancerologia de Queretaro S.C. /ID# 125920
Santiago de Querétaro , 76178, Mexico
Vrije Universiteit Medisch Centrum /ID# 125578
Amsterdam , 1081 , Netherlands
Amphia Ziekenhuis /ID# 126466
Breda , 4818 , Netherlands
Catharina Ziekenhuis /ID# 125577
Eindhoven , 5623 , Netherlands
Ziekenhuis St. Jansdal /ID# 125576
Harderwijk , 3844 , Netherlands
Atrium-Orbis Zuyderland Medisch Centrum /ID# 125710
Heerlen , 6419 , Netherlands
Jeroen Bosch Ziekenhuis /ID# 125709
S Hertogenbosch , 5223 , Netherlands
Isala /ID# 125579
Zwolle , 8025 , Netherlands
Wellington Hospital (Capital and Coast District Health Board) /ID# 125755
Wellington , 6021, New Zealand
Haukeland University Hospital /ID# 126338
Bergen Hordaland, 5021, Norway
Nordland Hospital /ID# 126337
Bodø , 8005, Norway
Sorlandet Sykehus HF /ID# 126341
Kristiansand , 4615, Norway
Oslo Universitetssykehus, Radiumhospitalet /ID# 126335
Oslo , 0310, Norway
Stavanger University Hospital /ID# 126336
Stavanger , 4068, Norway
Sykehuset i Vestfold HF /ID# 126340
Tonsberg , 3116, Norway
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 126548
Rzeszów Podkarpackie, 35-02, Poland
Szpital Morski im. PCK /ID# 126547
Gdynia , 81-51, Poland
NZOZ Magodent Ctr. Med. Ostro /ID# 126545
Warsaw , 04-12, Poland
Mazowiecki Szpital Onkologiczn /ID# 126546
Wieliszew , 05-13, Poland
Hospital Senhora da Oliveira de Guimaraes, EPE /ID# 126761
Guimaraes Braga, 4835-, Portugal
CCA Braga - Hospital de Braga /ID# 125837
Braga , 4710-, Portugal
Ctr Hosp Univ Coimbra, EPE /ID# 125838
Coimbra , 3000-, Portugal
Hospital Pulido Valente /ID# 125835
Lisbon , 1769-, Portugal
IPO Porto FG, EPE /ID# 125836
Porto , 4200-, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 125875
Porto , 4200-, Portugal
VA Caribbean Healthcare System /ID# 124562
San Juan , 00921, Puerto Rico
Federal State Budgetary Scientific Institution N.N. Blokhin Russian Cancer Resea /ID# 128458
Moscow Moskva, 11547, Russian Federation
Sverdlovsk Regional Oncology Center Dispensary /ID# 128457
Ekaterinburg Sverdlovskaya Oblast, 62004, Russian Federation
Volgograd Regional Clinical Oncology Dispensary /ID# 126350
Volgograd Volgogradskaya Oblast, 40013, Russian Federation
Belgorod Oncology Dispensary /ID# 129899
Belgorod , 30801, Russian Federation
State Budgetary Healthcare Institution"Irkutsk Regional Oncology Center /ID# 128460
Irkutsk , 66403, Russian Federation
State Regional Budgetary Healthcare Institution " Murmansk Regional Oncology Dis /ID# 128461
Murmansk , 18304, Russian Federation
Orenburg Regional Clinical Onc /ID# 137474
Orenburg , 46002, Russian Federation
Ogarev Mordovia State Univ /ID# 127595
Saransk , 43000, Russian Federation
Smolensk Regional Onc Clin Dis /ID# 127144
Smolensk , 21400, Russian Federation
Cancer Research Institute Siberian Branch of the Russian Academy of Medical Scie /ID# 127143
Tomsk , 63405, Russian Federation
Clinical Center Serbia /ID# 128738
Belgrade Beograd, 11000, Serbia
Clinical Center of Nis /ID# 128735
NIS Nisavski Okrug, 18000, Serbia
Institute for Oncology and Rad /ID# 128721
Belgrade , 11000, Serbia
University Hospital Bezanijska /ID# 128761
Belgrade , 11080, Serbia
Institute For Pulmonary Diseas /ID# 128737
Sremska Kamenica , 21204, Serbia
Univerzitna Nemocnica Bratislava /ID# 126342
Bratislava , 821 0, Slovakia
MEDEON, s.r.o. /ID# 128517
Pieštany , 921 0, Slovakia
GVI Oncology /ID# 126102
Port Elizabeth Eastern Cape, 6006, South Africa
Wits Clinical Research Site /ID# 126101
Johannesburg Gauteng, 2193, South Africa
Sandton Oncology Centre /ID# 126097
Johannesburg Gauteng, 2199, South Africa
University of Pretoria /ID# 127297
Pretoria Gauteng, 0001, South Africa
Dr Albert, Bouwer and Jordaan Incorporated /ID# 126098
Pretoria Gauteng, 0044, South Africa
Mary Potter Oncology Centre /ID# 126099
Pretoria Gauteng, 0181, South Africa
The Oncology Centre /ID# 126096
Durban Kwazulu-Natal, 4091, South Africa
Netcare Oncology Intervent Ctr /ID# 126100
Cape Town Western Cape, 7460, South Africa
Cancercare Outeniqua Oncology Unit /ID# 126103
George Western Cape, 6530, South Africa
Hospital Duran i Reynals /ID# 125161
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Universitario Puerta de Hierro Majadahonda /ID# 125160
Majadahonda Madrid, 28222, Spain
Hospital Universitario Vall d'Hebron /ID# 125159
Barcelona , 08035, Spain
Hospital Universitario HM Sanchinarro /ID# 125162
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio /ID# 125207
Sevilla , 41013, Spain
Fundacion Instituto Valenciano Oncologia IVO /ID# 125205
Valencia , 46009, Spain
Gavle Sjukhus /ID# 126444
Gavle , 803 2, Sweden
Sahlgrenska University Hosp /ID# 129997
Goteborg , 413 4, Sweden
University Hospital Linkoping /ID# 126443
Linkoping , 581 8, Sweden
Karolinska Univ Sjukhuset /ID# 126445
Solna , 17176, Sweden
Kantonsspital St. Gallen /ID# 126349
St. Gallen Sankt Gallen, 9007, Switzerland
Hirslanden Medical Center /ID# 128216
Aarau , 5000, Switzerland
Inselspital, Universitaetsklinik /ID# 126347
Bern , 3010, Switzerland
Spital STS AG /ID# 126348
Thun , 3600, Switzerland
Akdeniz University Medical Fac /ID# 126997
Antalya , 07059, Turkey
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 126186
Istanbul , 34098, Turkey
Marmara University Medical Fac /ID# 126187
Istanbul , 34899, Turkey
Ege University Medical Faculty /ID# 126189
Izmir , 35040, Turkey
Dr. Suat Seren Gogus Has /ID# 126190
Izmir , 35110, Turkey
Communal non-profit enterprise Regional Center of Oncology /ID# 128221
Kharkiv Kharkivska Oblast, 61070, Ukraine
Cherkassy Regional Onc Ctr /ID# 128222
Cherkasy , 18000, Ukraine
Regional Municipal Non-Profit Enterprise Bukovynian Clinical Oncology Center /ID# 128220
Chernivtsi , 58013, Ukraine
Municipal Non-Profit Enterprise City Clinical Hospital No.4 of Dnipro City Counc /ID# 128217
Dnipro , 49102, Ukraine
Lviv Oncological Regional Therapeutical and Diagnostic Centre /ID# 128218
Lviv , 79031, Ukraine
Poltava Regional Clinical Oncology Centre of Poltava Regional Council /ID# 128223
Poltava , 36011, Ukraine
Municipal Non-Profit Enterprise of Sumy Regional Council Sumy Regional Clinical /ID# 128219
Sumy , 40022, Ukraine
Cheltenham General Hospital /ID# 125692
Cheltenham Gloucestershire, GL53 , United Kingdom
Guy's and St Thomas' NHS Found /ID# 125694
London London, City Of, SE1 9, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 125697
Norwich Norfolk, NR4 7, United Kingdom
Betsi Cadwaladr Univ Health Bo /ID# 127177
Bangor , LL57 , United Kingdom
North Devon District Hospital /ID# 125689
Barnstaple , ES31 , United Kingdom
The Royal Bournemouth Hospital /ID# 125690
Bournemouth , BH7 7, United Kingdom
East Kent Hosp Univ NHS Trust /ID# 125698
Canterbury , CT1 3, United Kingdom
Gartnavel General Hospital /ID# 126233
Glasgow , G12 0, United Kingdom
James Paget University Hosp /ID# 125696
Great Yarmouth , NR31 , United Kingdom
Charing Cross Hospital /ID# 125688
London , W6 8R, United Kingdom
Maidstone Hospital /ID# 125693
Maidstone , ME16 , United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Freeman Hospital /ID# 129228
Newcastle Upon Tyne , NE7 7, United Kingdom
The Clatterbridge Cancer Ctr /ID# 125695
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

970

Study ID:

NCT02106546

Recruitment Status:

Completed

Sponsor:


AbbVie

How clear is this clinincal trial information?

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