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NCT01847274

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian CancerNova logo

Note: This study is also known as the NOVA Study.

Study identifier: NCT01847274
Full study details on clinicaltrials.gov

Name of PARP Inhibitor used in study:

Niraparib (Tesaro)

Eligibility:

  • High grade (or grade 3) serous histology or known to have a BRCA mutation
  • Has received at least 2 previous courses of platinum-containing therapy, and has disease that was considered platinum sensitive following the penultimate (next to last) platinum course (more than 6 month period between penultimate platinum regimen and progression of disease)
  • Has response to last the platinum regimen, remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen
  • Must not have received any prior PARP inhibitor therapy

Type of study:

Randomized Phase III

Treatment:

  • Patients are randomized to receive either niraparib as maintenance therapy or placebo in 2:1 ratio (2 people will be randomized to niraparib for every 1 person randomized to placebo). Agent will be administered once daily continuously during a 28 day cycle.

Study sites:

Study sites:

Contact study coordinators below where listed. For more information about NOVA and all open sites contact:

Beth Zaharoff: bzaharoff@tesarobio.com

Arizona
Phoenix
St. Joseph's Hospital and Medical Center
Div. Gynecologic Oncology
Principal Investigator: Dr. Bradley Monk
Study Coordinator: Catherine Newitt at:
Catherine.Newitt@DignityHealth.org or 602-406-2141

Tucson
Arizona Oncology Associates, PC — HOPE
Principal Investigator: Dr. Joseph Buscema
Study Coordinator: Leona Downey: ldowney@azcc.arizona.edu or 520-324-4778

California
Los Angeles
Cedars-Sinai Medical Center
Principal Investigator: Dr. Bobbie Rimel
Study Coordinator: Meredith Axtell: meredith.axtell@cshs.org or: 310-423-3348

Southern California Permanente Medical Group
Principal Investigator: Dr. Steven Vasilev
Study Coordinator: Sandra Baker-Bolden sandra.t.baker@kp.org or: 323-783-5532

Stanford
Stanford Cancer Institute
Principal Investigator: Dr. Jonathan Berek
Study Coordinator: Sharanya Ramasubramanian: sharanya@stanford.edu or 1 650-724-3308

Florida
Sarasota
Florida Cancer Specialists
Principal Investigator: Dr. Patel Manish
Study Coordinator: Jill Martin or 941-377-9993

Tampa
Moffit Cancer Center
Principal Investigator: Dr. Robert Wenham
Study Coordinator: Jennifer Tiemann: Jennifer.tiemann@moffitt.org or 813-745-727

Georgia
Atlanta
University Gynecologic Oncology
Principal Investigator: Dr. Benedict Benigno
Study Coordinator: Penny Daugherty:
penny.daugherty@segynonc.com or 404-300-2990

Illinois
Chicago
Northwestern University
Principal Investigator: Dr. Nikki Neubauer
Study Coordinator: Doreine Carson: doreine.carson@nmff.org or 312-472-4684

Indiana
Indianapolis
IU Melvin and Bren Simon Cancer Center
Principal Investigator: Dr. Daniela Matei
Study Coordinator: Carol Kulesavage: dmatei@iupui.edu or 317-278-0070

St. Vincent Hospital
Principal Investigator: Gregory Sutton
Study Coordinator: Shirley Morrison samorri1@stvincenet.org or +1-317-415-6747

Massachusetts
Boston
Harvard Medical School (HMS) - Dana Farber Cancer Institute
Principal Investigator: Dr. Ursula Matulonis
Study Coordinator: Kristen Savoie: Kristen_Savoie@DFCI.HARVARD.EDU or 617 632-2625

Minnesota
Minneapolis
Minnesota Oncology
Principal Investigator: Dr. Matthew Boente
Study Coordinator: Lynn Anderson: lynn.anderson@usoncology.com or 1- 612-884-6331

New Jersey
Morristown
Morristown Memorial Hospital
Morristown Medical Center Carol G. Simon Cancer Center
Principal Investigator: Dr. Brian Slomovitz
Study Coordinator: Maureen Nowakowski: maureen.nowakowski@atlantichealth.org or 973-971-5569

New Mexico
Farmington
San Juan Regional Cancer Center - San Juan Oncology Association
Principal Investigator: Dr. Jeffrey Neidhart
Study Coordinator:Rosemarie Mestas or 505-564-6874

North Carolina
Durham
Duke University Medical Center
Principal Investigator: Dr. Angeles Secord
Study Coordinator: Jennifer Mewshaw: Jennifer.Mewshaw@mc.duke.edu or 1 919-684-9074

Winston - Salem
Wake Forest Comprehensive Cancer Center
Principal Investigator: Dr. Michael Kelly
Study Coordinator: Melissa Swain: mswain@wakehealth.edu +1 336-716-9428

Ohio
Toledo
The University of Toledo Medical Center
Principal Investigator: Dr. John Geisler
Study Coordinator: Stephanie Smiddy: Stephanie.smiddy@utoledo.edu or 419-383-6794

Oklahoma
Oklahoma City
University of Oklahoma/Sarah Cannon Research Institute
Principal Investigator: Dr. Kathleen Moore
Study Coordinator: Kelsey Williams: Kelsey-Williams@ouhsc.edu or 405-271-8001 x48657

Pennsylvania
Abington
Abington Memorial Hospital
Principal Investigator: Dr. Pariz Hanjani
Study Coordinator: Karen Sweeney (ksweeney@amh.org) (1-215-885-0220

Tennessee
Nashville
The Sarah Cannon Research Institute
Principal Investigator: Dr. Howard Burris
Study Coordinator: Tabitha Hunt or 615-329-7274

Texas

Austin
Texas Oncology — Central
Principal Investigator: Dr. Michael Teneriello
Contact PI: teneriello@aol.com or +1512-302-1771

Dallas
UT Southwestern Medical Center
Principal Investigator: Dr. David Miller
Study Coordinator: Melana Lindsay Melana.Lindsay@UTSouthwestern.edu 214-648-7094

Fort Worth
Texas Oncology - Fort Worth
Principal Investigator: Dr. Noelle Cloven
Study Coordinator: Contact Texas Oncology texasoncology@usoncology.com or 239-334-6626

San Antonio
Cancer Care Centers of South Texas-HOAST
Principal Investigator: Dr. Antonio Santillan-Gomez
Study Coordinator: Contact Dr. Antonio Santillan-Gomez: antonio.santillan@usoncology.com or
210-595-5300

The Woodlands
Texas Oncology-The Woodlands
Principal Investigator: Dr. Christine Lee
Contact PI: christine.lee@usoncology.com or 281-296-0365

Washington
Vancouver
Northwest Cancer Specialists
Principal Investigator: Dr. Colleen McCormick
Contact PI: colleen.mccormick@usoncology.com: or +1 360-449-6521


International sites

Austria
Innsbruck
Universit�tsklinik f�r FRAUENHEILKUNDE Innsbruck
Principal Investigator: Dr. Christian Marth
Study Coordinator: Regina Berger regina.berger@i-med.ac.at (+4351250424132)

Graz
LKH-Univ. Klinikum Graz
Principal Investigator: Prof. Edgar Petru
Study Coordinator: Andrea Renate Lugert: renate.lugert@klinikum-graz.at or +43 316 385 80437

Belgium
Gasthuisberg
UZ Leuven - Campus Gasthuisberg
Principal Investigator: Prof. Ignace Vergote
Study Coordinator: Joke De Roover:
joke.deroover@uzleuven.be or phone: +32 16 34 74 19

Denmark
Region Hovedstaden
Herlev Hospital
Principal Investigator: Dr. Hanne Havsteen
Study Coordinator: Hanne Michelsen: Hanne.Marie.Michelsen@regionh.dk or +4538689130

Rigshospitalet - Region Hovedstaden [Oncology]
Principal Investigator: Dr. Mansoor Mirza
Study Coordinator: Pia Miller, RN: pia.miller@regionh.dk or phone: +45 35459540

Odense
Odense Universitetshospital
Odense Universitetshospital Lungemedicinsk afdeling J Sdr. Boulevard 29, indgang 87-88 Odense 5000
Region Syddanmark
Study Coordinator:
Vicki Nielsen: Vicki.nielsen@ouh.regionsyddanmark.dk or phone: +45 6541 1661

Aalborg
Arhus Universitetshospital - Aalborg Sygehus
Principal Investigator: Dr Bente Lund
Study Coordinator: Kirsten Lambaek:
kirsten.lambaek@rn.dk or phone: +45 9932 8052

France
Montpellier
CRLC Val d'Aurelle [Oncologie Mé dicale]
Principal Investigator: Dr. Michel Fabbro
Study Coordinator: Christine Gestin-Boyer:
Christine.Gestin-Boyer@icm.unicancer.fr
or phone (+33467612515)

Saint-Herblain
Centre Rene Gauducheau
Principal Investigator: Dr. Dominique Berton-Rigaud
Study Coordinator: Béatrice Saulquin:
beatrice.saulquin@ico.unicancer.fr or phone+33 2 40 67 99 03)

Norway
Hordaland
Haukeland University Hospital
Principal Investigator: Dr. Kathrine Woie
Study Coordinator: Liv Kirsten Andersen:
liv.kirsten.styve.andersen@helse-bergen.no or (+47 05300)

Oslo
Oslo University Hospital Radium Hospitalet Montebello
Principal Investigator: Dr. Anne Dorum
Study Coordinator: Ellen Stover:
estoev@ous-hf.no or (+4722935149)

Poland
Gdansku
Wojewodzkie Centrum Onkologii w Gdansku
Principal Investigator: Dr. Joanna Pikiel
Study Coordinator: Joanna Karczewska bk@wco.gda.pl or +48 58 3452069

Spain
Baleares
Hospital Son Llatzer
Principal Investigator: Dr. Isabel Maria Bover Barcelo
Study Coordinator: Sergio Ayuga Rossell: ibover@hsll.es or +34 871 20 21 01

Madrid
Hospital Universitario La Paz Paseo de la Castellana
Principal Investigator: Dr. Andres Redondo Sanchez
Study Coordinator: Yolanda Álvarez Pérez yolandalapaz@gmail.com or +34917277000

Sweden
Lund
Lund University Hospital
Principal Investigator: Dr. Susanne Malander
Study Coordinator: Anna Weddig anna.weddig@skane.se or +46 46 17 85 36

United Kingdom
London
University College Hospital [Oncology]
Principal Investigator: Prof Jonathan A Ledermann
Study Coordinator: Egla Aitkens:
egla.aitkens@uclh.nhs.uk or phone: +44 20 3447 7832

The Royal Marsden NHS Foundation Trust
Principal Investigator: Dr. Susana Banerjee
Study Coordinator: Lesley Murphy:
lesley.murphy@rmh.nhs.uk
or phone +44 20 7811 8084

Nottingham
Nottingham City Hospital
Principal Investigator: Dr. Stephen Chan
Study Coordinator: Louisa Jones: louisa.jones@nuh.nhs.uk or +441159691169 (ext) 57603

Wirral
Clatterbridge Centre for Oncology
Principal Investigator: Dr. Rosemary Lord
Study Coordinator: Yvonne McCarthy: Yvonne.McCarthy@clatterbridgecc.nhs.uk (+441513341155 ext 4924)

Yeovil
Yeovil District Hospital NHS Foundation Trust
Principal Investigator: Dr. Clare Barlow
Study Coordinator: Joanna Allison: Joanna.Allison@YDH.NHS.UK or +44 01935 384615

Ysbyty Gwynedd
Maidstone and Tunbridge Wells NHS Trust
Principal Investigator: Dr. Justin Waters
Study Coordinator: Loraine Hennessey: loraine.hennessey@nhs.net or +44 01622 227039

For questions about this study, Refer to ClinicalTrials.gov identifier: NCT01847274

Page updated 03/07/14