Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
PRESENT
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
2 other identifiers
interventional
758
13 countries
197
Brief Summary
Purpose of this trial:
- 1.To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF).
- 2.To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Longer than P75 for phase_3
197 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 20, 2011
CompletedFirst Posted
Study publicly available on registry
November 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2016
CompletedFebruary 27, 2017
February 1, 2017
4.9 years
November 20, 2011
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of DFS in vaccine treated patients and control patients
The primary objective is to compare the DFS in subjects with operable early-stage, node-positive breast cancer who receive standard of care multimodality therapy plus NeuVax™ as the treatment group or standard of care multimodality therapy plus the vaccine adjuvant, Leukine® as the control group.
36 months
Secondary Outcomes (1)
Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety
3 through 10 years
Study Arms (2)
NeuVax™
EXPERIMENTALNeuVax™ in WFI solution with Leukine®
Leukine®
ACTIVE COMPARATORLeukine® with WFI
Interventions
E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, NeuVax™ vaccine boosters will be given the same way once every six months for the next five times (totaling 36 months).
Leukine® 250 micrograms in water for injection, will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, boosters inoculations will be given the same way once every six months for the next five times (totaling 36 months).
Eligibility Criteria
You may qualify if:
- Pathological diagnosis of invasive adenocarcinoma of the breast
- Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
- One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II:
- Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
- BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes
- Node-positive disease
- Primary tumor stage T1-3 at initial diagnosis
- HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)
- HLA-A2 or HLA-A3 haplotype
- Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
- Completed radiation therapy
- No evidence of disease
- Able and willing (or have legal representative) to understand the study and provide consent
You may not qualify if:
- Bilateral breast malignancy or suspicious mass in opposite breast
- Inflammatory breast malignancy
- History of prior breast cancer, ductal carcinoma in situ
- Prior trastuzumab therapy
- New York Heart Association Stage 3 or 4 cardiac disease
- Sensory/motor neuropathy ≥ Grade 2
- Autoimmune diseases or immune deficiency disease
- Subjects on chronic steroid therapy, other immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (197)
Alabama Oncology
Bessemer, Alabama, 35022, United States
Physicians Pain Specialists of Alabama, P.C.
Mobile, Alabama, 36606, United States
Pain Centers Nationwide
Peoria, Arizona, 83582, United States
Valley Pain Consultants
Scottsdale, Arizona, 85254, United States
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505, United States
Coastal Pain Research
Carlsbad, California, 92009, United States
Navajo Road Pain Management Center
El Cajon, California, 92020, United States
California Cancer Associates for Research and Excellence, Inc.
Fresno, California, 93720, United States
California Cancer Associates For Research and Excellence
Fresno, California, 93720, United States
St. Jude Medical Center, Virginia K. Crosson Cancer Center
Fullerton, California, 92801, United States
Interventional Pain Management
Irvine, California, 92618, United States
South Orange County Surgical Medical Group
Laguna Hills, California, 92653, United States
University of Southern California/Norris Cancer Hospital
Los Angeles, California, 90033, United States
Alexander Ford, MD
Los Angeles, California, 90035, United States
Cancer Care Institute
Los Angeles, California, 90036, United States
Pete J. Ruane, MD, Inc.
Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048, United States
Moores UC San Diego Cancer Center (UCSD)
San Diego, California, 92093, United States
University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Pain Institute of Santa Monica
Santa Monica, California, 90404, United States
Randy Scharlach, MD
Woodland Hills, California, 91367, United States
University of Colorado Cancer Center, Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Red Rocks Center for Rehabilitation
Golden, Colorado, 80401, United States
Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut, 06810, United States
Stamford Hospital, Bennett Cancer Center
Stamford, Connecticut, 06904, United States
Pain Management Associates of CT, PC
Stamford, Connecticut, 06905, United States
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, 33180, United States
Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida, 33308, United States
Cancer Specialists of North Florida (ICON)
Jacksonville, Florida, 32256, United States
MD Anderson Center-Orlando Health
Orlando, Florida, 32806, United States
Florida Cancer Research Institute (Florida Cancer Care)
Plantation, Florida, 33317, United States
Florida Cancer Care
Plantation, Florida, 33324, United States
H.Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Northeast Georgia Cancer Care
Athens, Georgia, 30607, United States
Interventional Spine and Pain Management
Atlanta, Georgia, 30309, United States
Central Georgia Cancer Care
Macon, Georgia, 31201, United States
Cancer Treatment Centers of America
Newnan, Georgia, 30265, United States
Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center
Chicago, Illinois, 60611, United States
Pain Management Institute
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Center of Cancer and Blood Disorders (VEEDA network)
Bethesda, Maryland, 20817, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Lahey Clinic Department of Hematology and Oncology
Burlington, Massachusetts, 01805, United States
Physiatry Consultants
Bay City, Michigan, 48796, United States
Michigan Interventional Pain Center
Brownstown, Michigan, 48183, United States
William Beaumont Hospital Cancer Center
Royal Oak, Michigan, 48071, United States
Glenn Saperstein, D.O., LLC
Saginaw, Michigan, 48604, United States
Advanced Physical Medicine
Saint Clair Shores, Michigan, 48080, United States
Fountain Medical Group
New York, New York, 10021, United States
Weill Cornell Medical College
New York, New York, 100665, United States
Upper East Side Pain Medicine, P.C.
New York, New York, 36607, United States
Comprehensive Pain Management
Syosset, New York, 11791, United States
Eastchester Cancer Care Center
The Bronx, New York, 10469, United States
APWI
Williamsville, New York, 14221, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
St. Alexius Medical Center, Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
Akron General Medical Center
Akron, Ohio, 44302, United States
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97239, United States
Gettysburg Cancer Center
Hillsdale, Pennsylvania, 17325, United States
Conemaugh Memorial Hospital-Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
J. Fred Stoner, MD
New Castle, Pennsylvania, 16101, United States
University of Pittsburgh Medical Center (UPMC) Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Progressive Pain Solutions
Wind Gap, Pennsylvania, 18091, United States
Jerrold Rosenberg, MD
Providence, Rhode Island, 02904, United States
The West Clinic Comprehensive Breast Center
Germantown, Tennessee, 38138, United States
The West Clinic
Memphis, Tennessee, 38120, United States
PRIDE
Dallas, Texas, 75235, United States
UT Southwestern Medical Center / Simmons Comprehensive Cancer Center
Dallas, Texas, 75390, United States
Brooke Army Medical Center (now SAMMC)
Fort Sam Houston, Texas, 78234, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78229, United States
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Swedish Cancer Institute Research
Seattle, Washington, 98104, United States
Multicare Health System-Research Institute
Tacoma, Washington, 98405, United States
Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center
Milwaukee, Wisconsin, 52336, United States
Central Onco Hospital
Plovdiv, 4002, Bulgaria
Serdika
Sofia, 1303, Bulgaria
Tsaritsa Yoanna - ISUL
Sofia, 1527, Bulgaria
Sveta Marina
Varna, 9010, Bulgaria
Complex Oncology Center, Veliko Tarnovo
Veliko Tarnovo, 5000, Bulgaria
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2, Canada
Health Sciences North Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Hospital Charles LeMorne
Greenfield Park, Quebec, J4V 2H1, Canada
Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic
Brno, 656 53, Czechia
University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy
Hradec Králové, 500 05, Czechia
University Hospital Olomouc, Clinic of Oncology
Olomouc, 775 20, Czechia
General University Hospital in Prague, Clinic of Oncology
Prague, 128 08, Czechia
Institut de Cancérologie de l'Ouest Siet Paul Papin
Angers, Cedex 9, 49933, France
Centre Oscar Lambret
Cédex, Lille, 59020, France
Institut de Cancérologie de l'Ouest/René Gauducheau
Saint Herblain, Nantes Cedex, Loire-Atlantique, 44805, France
Centre Antoine Lacassagne
Nice, 06189, France
Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum
Berlin, 10117, Germany
Brustzentrum Klinikum Bremen-Mitte gGmbH
Bremen, 28177, Germany
Universitätsklinikum Erlangen, Frauenklinik
Erlangen, D-91054, Germany
Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum
Essen, D-45136, Germany
Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe
Frankfurt, 60590, Germany
Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie
Heidelberg, 69120, Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105, Germany
Universität Marburg
Marburg, 35043, Germany
Rotkreuzklinikum München gGmbH, Frauenklinik
München, 80637, Germany
Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
Münster, 48149, Germany
Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik
Stuttgart, 70374, Germany
Klinikum Mutterhaus der Borromaeerinnen
Trier, 54290, Germany
Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker
Würzburg, D-97080, Germany
Hetenyi Geza Hospital, Department of Oncology
Szolnok, Jász-Nagykun-Szolnok, H-5000, Hungary
Szent Margit Hospital, V. Department of Internal Medicine, Oncology
Budapest, H-1032, Hungary
Semmelweis University, Department of Diagnostic Radiology and Oncotherapy
Budapest, H-1083, Hungary
Petz Aladar County Teaching Hospital, Center for Oncoradiology
Győr, H-9024, Hungary
Kaposi Mor County Teaching Hospital, Center for Clinical Oncology
Kaposvár, 7400, Hungary
Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology
Miskolc, 3526, Hungary
Rambam Health Care Campus
Haifa, Haifa District, 31096, Israel
Sheba Medical Centre
Tel Hasomer, Ramat Gan, 52621, Israel
Rabin Medical Centre
Petah Tikva, 49100, Israel
Kaplan Medical Centre
Rehovot, 76100, Israel
Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy
Kamienskiego, Wroclaw, 51-124, Poland
Polish Red Cross Marine Hospital, Department of Chemotherapy
Gdynia, 81-519, Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy
Lodz, 93-513, Poland
Greater Poland Cancer Center, Department of Chemotherapy
Poznan, 61-866, Poland
Magodent
Warsaw, 04-125, Poland
Non-Public Health Care Facility MAGODENT
Warsaw, 04-125, Poland
"Gavril Curteanu" Municipal Clinical Hospital
Oradea, Bihor County, 410469, Romania
Medisprof SRL, Department of Medical Oncology
Cluj-Napoca, Cluj, 400058, Romania
Oncology Center "Sf. Nectarie", Department of Medical Oncology
Craiova, Dolj, 200347, Romania
Dr. Constantin Opris County Emergency Hospital, Department of Oncology
Baia Mare, Maramures, 430031, Romania
Filantropia Clinical Hospital, Obstetrics and Gynaecology Department
Bucharest, 011171, Romania
Coltea Clinical Hospital, Oncology Department
Bucharest, 030171, Romania
Bucharest Universtiy Emergency Hosptial, Oncology Department
Bucharest, 050098, Romania
"Prof. Dr. Ion Chiricuta" Institute of Oncology
Cluj-Napoca, 400015, Romania
Iasi Regional Oncology Institute, Department of Medical Oncology
Iași, 700483, Romania
Oncomed SRL, Department of Medical Oncology
Timișoara, 300239, Romania
Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration
Sochi, Krasnodarskiy Kray, 354057, Russia
Republican Oncology Center
Saransk, Respublika Mordoviya, 430032, Russia
Pyatigorsk Oncology Center
Pyatigorsk, Stavropol Kray, 357502, Russia
Republican Clinical Oncoogy Center
Kazan', Tatarstan Republic, 420029, Russia
Arkhangelsk Clinical Oncology Center
Arkhangelsk, 163045, Russia
Regional Oncology Center
Irkutsk, 664035, Russia
Ivanovo Regional Oncology Center
Ivanovo, 153040, Russia
Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration
Krasnodar, 350040, Russia
Krasnoyarsk Kryzhanovsky Regional Oncology Center
Krasnoyarsk, 660133, Russia
Kursk Regional Clinical Oncology Center
Kursk, 305035, Russia
N.N. Blokhin Russian Cancer Research Center
Moscow, 115478, Russia
N.N. Blokhin Russian Cancer Reserach Center
Moscow, 115478, Russia
Clinical Diagnostics Center
Nizhny Novgorod, 603006, Russia
Nizhny Novgorod Regional Oncology Center
Nizhny Novgorod, 603081, Russia
Orenburg Regional Clinical Oncology Center
Orenburg, 460051, Russia
Orel Oncology Center
Oryol, 302020, Russia
Medical Institution of Ryazan Region
Ryazan, 390011, Russia
Leningrad Regional Oncology Center
Saint Petersburg, 191104, Russia
St. Petersburg Clinical Hospital
Saint Petersburg, 194017, Russia
Mechnikov North-Western State Medical University
Saint Petersburg, 195067, Russia
Petrov Research Institute of Oncology
Saint Petersburg, 197758, Russia
Municipal Clinical Oncology Center
Saint Petersburg, 198255, Russia
Samara Regional Clinical Oncology Center
Samara, 443031, Russia
Tambov Regional Clinical Oncology Center
Tambov, 392013, Russia
Research Institute of Oncology
Tomsk, 634028, Russia
Bashkir State Medical University
Ufa, 450000, Russia
Regional Clinical Oncology Center
Veliky Novgorod, 173016, Russia
Volgograd Regional Oncology Center #3
Volzhskiy, 404130, Russia
Yaroslavl Regional Oncology Center
Yaroslavl, 150054, Russia
Sverdlovsk Regional Oncology Center
Yekaterinburg, 620036, Russia
Clinical Diagnostics Center
Simferopol, Autonomous Republic of Crimea, 95000, Ukraine
Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy
Kryvyi Rih, Dnipropetrovsk Oblast, 50000, Ukraine
Mariupol City Interdistrict Oncology Center, Surgery Department #2
Mariupol, Donetsk Oblast, 87500, Ukraine
Kharkiv Regional Clinical Oncology Center, Day Care Unit
Kharkiv, Kyivskyi District, 61070, Ukraine
Chernivtsi Regional Clinical Oncology Center, Day Care Unit
Chernivtsi, 58013, Ukraine
Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy
Dnipropetrovsk, 49102, Ukraine
Donetsk City Oncology Center
Donetsk, 83087, Ukraine
Donetsk Regional Antitumor Center, Oncosurgery Department #2
Donetsk, 83092, Ukraine
State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine
Kharkiv, 61024, Ukraine
Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council
Kiev, 04107, Ukraine
Kirovohrad Regional Oncology Center, Department of Mammology
Kirovohrad, 25011, Ukraine
Kyiv City Clinical Oncology Center, Department of Chemotherapy
Kyiv, 03115, Ukraine
Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
Lviv, 79031, Ukraine
Odesa Regional Clinical Hospital, Center for Mastology
Odesa, 65000, Ukraine
Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
Uzhhorod, 88014, Ukraine
Vinnytsia Regional Clinical Oncology Center
Vinnytsia, 21029, Ukraine
Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council
Zaporizhia, 69040, Ukraine
Macclesfield District General Hospital
Macclesfield, Cheshire, SK10 3BL, United Kingdom
The Christie NHS Foundation Trust
Withington, Manchester, M20 4BX, United Kingdom
James Cook University Hospital
Middlesbrough, Middlesborough, TS4 3BW, United Kingdom
Plymouth Oncology Centre, Derriford Hospital
Plymouth, Plymouth, PL6 8DH, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
Leeds Teaching Hospitals Trust, St. James University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Leicester Royal Infirmary
Leicester, LE1 5WW, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Academic Unit of Oncology, Nottingham University Hospital-City Campus
Nottingham, NG7 2UH, United Kingdom
Weston Park Hospital
Sheffield, S10 2SJ, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
University Hospital of North Staffordshire
Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (3)
Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.
PMID: 18392824BACKGROUNDMittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.
PMID: 21989902BACKGROUNDMittendorf EA, Lu B, Melisko M, Price Hiller J, Bondarenko I, Brunt AM, Sergii G, Petrakova K, Peoples GE. Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial. Clin Cancer Res. 2019 Jul 15;25(14):4248-4254. doi: 10.1158/1078-0432.CCR-18-2867. Epub 2019 Apr 29.
PMID: 31036542DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A Mittendorf, MD,FACS
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2011
First Posted
November 24, 2011
Study Start
November 1, 2011
Primary Completion
September 21, 2016
Study Completion
September 21, 2016
Last Updated
February 27, 2017
Record last verified: 2017-02