Breast Cancer Clinical Trial

A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer

Summary

The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review.
Recurrent or persistent measurable disease that has progressed (defined as radiological and/or clinical progression; an increase in cancer antigen [CA]-125 alone is not sufficient) on or after last therapy (i.e., chemotherapy, hormonal therapy, surgery) and is not amenable to potentially curative intent surgery, as determined by the patient's treating physician.
Must have received at least 1 prior platinum-based chemotherapy regimen but have received no more than 3 lines of prior chemotherapy regimens, with no limit to the number of lines of prior hormonal therapy. Front-line therapy may include neoadjuvant and adjuvant therapy and will be counted as 1 prior systemic regimen. Biological therapy (e.g. bevacizumab) administered as a single agent is considered a prior systemic regimen and not a prior chemotherapy regimen. Maintenance therapy is not considered its own regimen but should be included with the regimen that it follows.
Available archival tumor sample (excisional or core biopsy) for confirmation of LGS carcinoma diagnosis. If adequate archival tumor sample is not available, willingness to consent to tissue biopsy.
Suitable for treatment with at least one of the physician's choice chemotherapy options (liposomal doxorubicin, paclitaxel or topotecan) as determined by the Investigator.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Additional criteria exist.

Key Exclusion Criteria:

History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes).
Prior therapy with a MEK or BRAF inhibitor.
History of Gilbert's syndrome.
Impaired cardiovascular function or clinically significant cardiovascular diseases.
Uncontrolled or symptomatic brain metastases that are not stable or require steroids, are potentially life-threatening or have required radiation within 28 days prior to first dose of study treatment.
Concomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis.
Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or active hepatitis C.
Prior randomization into this clinical study.
Additional criteria exist.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

341

Study ID:

NCT01849874

Recruitment Status:

Completed

Sponsor:

Pfizer

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 168 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Phoenix Arizona, 85004, United States
Associated Retina Consultants, Ltd.
Phoenix Arizona, 85020, United States
Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
Scottsdale Arizona, 85258, United States
Keck Hospital of USC
Los Angeles California, 90033, United States
LAC & USC Medical Center
Los Angeles California, 90033, United States
USC Healthcare Consultation Center 1
Los Angeles California, 90033, United States
USC Healthcare Consultation Center 2
Los Angeles California, 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology
Los Angeles California, 90095, United States
Doris Stein Research Center Building
Los Angeles California, 90095, United States
University of California Los Angeles, Hematology-Oncology Clinic
Los Angeles California, 90095, United States
Gynecologic Oncology Associates
Newport Beach California, 92663, United States
University of California, Irvine/UC Irvine Health
Orange California, 92868, United States
UCLA Hematology/Oncology Clinic - Santa Monica
Santa Monica California, 90404, United States
UCLA Hematology Oncology Clinic Santa Clarita
Valencia California, 91355, United States
UCLA Hematology - Oncology Clinic - Westlake Village
Westlake Village California, 91361, United States
Rocky Mountain Lions Eye Institute
Aurora Colorado, 80045, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
University of Colorado Denver, University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven Connecticut, 06510, United States
Eye Physicians of Central Florida
Maitland Florida, 32751, United States
Florida Hospital
Orlando Florida, 32803, United States
Florida Hospital Cancer Institute
Orlando Florida, 32804, United States
Eye Physicians of Central
Orlando Florida, 32835, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Florida Cancer Specialists
Wellington Florida, 33414, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Georgia Regents University Cancer Center
Augusta Georgia, 30912, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
St. Vincent Cancer Care
Indianapolis Indiana, 46260, United States
St. Vincent Gynecologic Oncology
Indianapolis Indiana, 46260, United States
St. Vincent Gynecology Oncology
Indianapolis Indiana, 46260, United States
St. Vincent Hospital and Health Care Center, Inc.
Indianapolis Indiana, 46260, United States
Associated Vitreoretinal and Uveitis Consultants
Indianapolis Indiana, 46290, United States
University of Iowa Hospitals and Clinics
Iowa City Iowa, 52242, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Ophthalmic Consultants of Boston (OCB)
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Kresge Eye Institute
Detroit Michigan, 48201, United States
Karmanos Cancer Institute
Farmington Hills Michigan, 48334, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Center for Advanced Medicine
Saint Louis Missouri, 63110, United States
Center For Clinical Studies
Saint Louis Missouri, 63110, United States
Washington University
Saint Louis Missouri, 63110, United States
Billings Clinic
Billings Montana, 59101, United States
University of New Mexico Cancer Center
Albuquerque New Mexico, 87106, United States
Eye Associates of New Mexico
Albuquerque New Mexico, 87109, United States
Montefiore Medical Center - Einstein Center for Cancer Care
Bronx New York, 10461, United States
Montefiore Medical Center
Bronx New York, 10461, United States
Montefiore Medical Center - Centennial Women's Health
Bronx New York, 10467, United States
Montefiore Medical Center, Green Medical Arts Pavilion
Bronx New York, 10467, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10022, United States
University of Cincinnati Medical Center
Cincinnati Ohio, 45219, United States
Fairview Hospital Moll Pavilion Cancer Center
Cleveland Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Cleveland Clinic-Main Campus
Cleveland Ohio, 44195, United States
James Cancer Hospital & Solove Research Institute
Columbus Ohio, 43210, United States
OSU Wexner Medical Center
Columbus Ohio, 43210, United States
Stefanie Spielman Comprehensive Breast Cancer
Columbus Ohio, 43212, United States
OSU Gynecologic Oncology at Mill Run
Hilliard Ohio, 43026, United States
Hillcrest Hospital
Mayfield Heights Ohio, 44124, United States
University of Cincinnati Physicians Company
West Chester Ohio, 45219, United States
Dean McGee Eye Institute
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center(clinic location)
Oklahoma City Oklahoma, 73104, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Jeanes Hospital
Philadelphia Pennsylvania, 19111, United States
Magee-Womens Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15213, United States
Parkland Health and Hospital System
Dallas Texas, 75235, United States
UT Southwestern Medical Center-Zale Lipshy University Hospital
Dallas Texas, 75235, United States
UT Southwestern Medical Center-Clements University Hospital
Dallas Texas, 75390, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Virginia
Charlottesville Virginia, 22903, United States
Dr Anil Arora
Wahroonga New South Wales, 2076, Australia
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Mater Misericordiae Health Services Brisbane Limited
South Brisbane Queensland, 4101, Australia
Adelaide Cardiology
Adelaide South Australia, 5000, Australia
Adelaide Eye and Retina Centre
Adelaide South Australia, 5000, Australia
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia
Thomas and Delaney Optometrists
Norwood South Australia, 5067, Australia
Burnside War Memorial Hospital
Toorak Gardens South Australia, 5065, Australia
Sunshine Hospital
St Albans Victoria, 3021, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Innsbruck Medical University
Innsbruck Tirol, A-602, Austria
Centre Hospitalier de l'ardenne
Libramont Luxembourg, 6800, Belgium
Private practice Ophthalmology
Libramont Luxembourg, 6800, Belgium
University Hospital Leuven
Leuven Vlaams-brabant, 3000, Belgium
Cliniques Universitaires Saint-Luc
Brussels , 1200, Belgium
Ghent University Hospital
Gent , 9000, Belgium
University Hospital Gent
Gent , 9000, Belgium
CHR de la Citadelle
Liege , 4000, Belgium
Clinique et Maternite Sainte-Elisabeth Namur
Namur , 5000, Belgium
Sint-Augustinus
Wilrijk , 2610, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver British Columbia, V5Z 4, Canada
CancerCare Manitoba
Winnipeg Manitoba, R2H 2, Canada
Juravinski Cancer Center, Department of Oncology
Hamilton Ontario, L8V 5, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
Montreal Quebec, H2L 4, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Teaching Hospital Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc
Olomouc , 775 2, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba , 708 5, Czechia
Fakultni Nemocnice Ostrava
Ostrava - Poruba , 70852, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba , 708 5, Czechia
General University Hospital in Prague
Prague 2 , 128 0, Czechia
General University Hospital in Prague
Prague , 120 0, Czechia
Aalborg Sygehus Apotek
Aalborg North Jutland, 9000, Denmark
Aalborg University Hospital
Aalborg North Jutland, 9000, Denmark
Herlev Hospital Onkologisk AFD
Herlev , 02730, Denmark
Region Hovedstadens Apotek
Kobenhavn o , 2100, Denmark
Rigshospitalet
Kobenhavn o , 2100, Denmark
Ojenklinikken 2061
København Ø , 2100, Denmark
Radiologisk Afdeling 2023
København Ø , 2100, Denmark
Tampere University Hospital
Tampere , FI-33, Finland
CHU Jean Minjoz
Besancon , 25000, France
Centre Oscar Lambret
Lille , 59000, France
Hopital Prive La Louviere
Lille , 59000, France
Centre Leon Berard
LYON Cedex 08 , 69373, France
Hopital Edouard Herriot
Lyon , 69003, France
Institut Paoli Calmettes - Departement d'Oncologie Medicale
Marseille Cedex 09 , 13273, France
Centre Paradis Monticelli
Marseille , 13008, France
Centre d'Ophtalmologie du LEZ Centre Medical Les Roques
Montferrier S/lez , 34980, France
Institut Regional du Cancer Montpellier
Montpellier CEDEX 5 , 34298, France
L'Hopital Prive du Confluent SAS
NANTES Cedex 2 , 44277, France
Cabinet Liberal du Dr Xavier Zanlonghi
Nantes , 44000, France
Clinique Sourdille
Nantes , 44000, France
Hopital Europeen Georges Pompidou
Paris Cedex 15 , 75908, France
Centre d'Investigations Cliniques 1423
Paris , 75012, France
Centre Investigateur CARIO - HPCA
Plerin , 22190, France
Institut de Cancerologie de I'Ouest - Rene Gauducheau
Saint-Herblain Cedex , 44805, France
Institut Gustave Roussy
Villejuif Cedex , 94805, France
Universitaets-Brustzentrum
Tuebingen Baden-wuerttemberg, 72076, Germany
Universitätsfrauenklinik Ulm
Ulm Baden-wurttemberg, 89075, Germany
Klinikum rechts der Isar
Munich Bavaria, 81675, Germany
Klinik fur Frauenheilkunde und Geburtshilfe
Kassel Hessen, 34125, Germany
Kliniken Essen-Mitte
Essen North Rhine-westphalia, 45136, Germany
Universitätsklinikum Bonn
Bonn North-rhine Westphalia, 53127, Germany
Uni Carl Gustav Carus
Dresden Saxony, 01307, Germany
Universitätsklinikum Schleswig-Holstein
Kiel Schleswig-holstein, 24105, Germany
Charité Universitaetsmedizin Berlin
Berlin , 13353, Germany
Universitaetsklinik Freiburg
Freiburg , 79106, Germany
Frauenheilkunde und Geburtshilfe
Greifswald , 17475, Germany
NCT Nationales Centrum für Tumorerkrankungen Heidelberg
Heidelberg , 69120, Germany
Euromedic Diagnostics Magyarorszag Kft.
Gyor Gyor-moson-sopron, 9023, Hungary
Petz Aladar Korhaz Kardiologiai Osztaly
Gyor Gyor-moson-sopron, 9024, Hungary
Petz Aladar Korhaz Szemeszeti Osztaly
Gyor Gyor-moson-sopron, 9024, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
Budapest , 1062, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest , 1062, Hungary
Semmelweis Egyetem AOK Szemeszeti Klinika
Budapest , 1088, Hungary
Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly
Budapest , 1122, Hungary
Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
Budapest , 1122, Hungary
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest , 1134, Hungary
St James's Hospital
Dublin Dublin 8, , Ireland
Istituto Clinico Humanitas
Rozzano Milano, 20089, Italy
Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C
Aviano Pordenone, 33081, Italy
Ospedale Civile degli Infermi - Servizio di Oculistica
Faenza Ravenna, 48018, Italy
Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica
Faenza Ravenna, 48018, Italy
Ospedale Umberto I - Unita Operativa di Oncologia
Lugo Ravenna, 48022, Italy
Istituto Nazionale Tumori Regina Elena - Oncologia Medica A
Roma RM, 00144, Italy
Policlinico Umberto I - Università Sapienza
Roma Rome, 00155, Italy
Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica
Roma Rome, 00189, Italy
SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi
Bologna , 40138, Italy
Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica
Brescia , 25123, Italy
Spedali Civili Di Brescia
Brescia , 25125, Italy
Azienda Ospedaliera Cannizzaro
Catania , 95216, Italy
Ospedale San Raffaele - Unita Operativa di Oculistica
Milano , 20132, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica
Milano , 20133, Italy
Istituto Europeo Oncologico
Milano , 20141, Italy
Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica
Napoli , 80131, Italy
Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico
Napoli , 80131, Italy
Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze
Napoli , 80131, Italy
Universita degli Studi Federico II di Napoli Oncologia Medica
Napoli , 80131, Italy
Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -
Pordenone , 33081, Italy
Ospedale Santa Maria delle Croci - Oculistica
Ravenna , 48121, Italy
Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia
Ravenna , 48121, Italy
Dipartimento Organi di Senso
Roma , 00161, Italy
Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica
Roma , 00168, Italy
Policlinico Agostino Gemelli
Roma , 00168, Italy
Academic Medical Center (AMC)
Amsterdam Noord-holland, 1150 , Netherlands
University Medical Center Groningen, Medical Oncology
Groningen , 9713 , Netherlands
Maastricht University Medical Centre
Maastricht , 6229 , Netherlands
Aleris
Oslo , 0264, Norway
Avd. for gynekologisk kreft, Radiumhospitalet
Oslo , 0379, Norway
Oslo Universitetssykehus HF
Oslo , 0450, Norway
Centralny Szpital Kliniczny MON
Warsaw , 04-14, Poland
Hospital Duran i Reynals
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Universitario Reina Sofía/ Provincial
Córdoba Castilla LA Mancha, 14004, Spain
Centro de Salud Anoeta
Anoeta Guipuzcoa, 20270, Spain
Hospital Universitario Donostia
San Sebastian Guipuzcoa, 20014, Spain
Ophthalmology at Instituto Oftalmologico Integral
Barcelona , 08017, Spain
Hospital Clinic Barcelona
Barcelona , 08036, Spain
Hospital de Sant Joan Despi Moises Broggi
Barcelona , 08970, Spain
Cardiology at Consulta de Cardiologia
Cordoba , 14004, Spain
Centro Medico Sanitas Ressalta
Cordoba , 14012, Spain
Instituto de Oftalmologia y Hospital La Arruzafa
Cordoba , 14012, Spain
Radiology at Centro Medico Sanitas Ressalta
Cordoba , 14012, Spain
Radiology at Hospital Univeristari de Bellvitge
L'Hospitalet de Llobregat , 08907, Spain
Hospital Ramón Y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Son Llatzer
Palma de Mallorca , 07198, Spain
Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain
Hospital Virgen de la Salud
Toledo , 45004, Spain
Fundacion IVO-Instituto Valenciano de Oncologia
Valencia , 46009, Spain
Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia
Valencia , 46026, Spain
Karolinska Universitetssjukhuset
Stockholm , 171 7, Sweden
Onkologkliniken Akademiska Sjukhuset
Uppsala , 751 8, Sweden
Sarah Cannon Research Institute UK
London England, W1G 6, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham Nottinghamshire, NG5 1, United Kingdom
University of Nottingham
Nottingham Nottinghamshire, NG7 2, United Kingdom
Ashtead Hospital
Ashtead Surrey, KT21 , United Kingdom
The Clock House Medical Practice
Epsom Surrey, KT18 , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton Surrey, SM2 5, United Kingdom
St. Anthony's Hospital
North Cheam Sutton, SM3 9, United Kingdom
City Hospital
Birmingham WEST Midlands, B18 7, United Kingdom
Royal Marsden NHS Foundation Trust
London , SW3 6, United Kingdom
The Harley Street Clinic
London , W1G 8, United Kingdom
London Eye Diagnostic Centre
London , W1G 9, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

341

Study ID:

NCT01849874

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.