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

The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer): A Multinational, Randomized, Open-label Phase 3 Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum

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.

Study Overview

• Status: Terminated
• Conditions: Low-grade Serous Ovarian Cancer; Low-grade Serous Fallopian Tube Cancer; Low-grade Serous Peritoneal Cancer
• Intervention / Treatment: Drug: MEK162, MEK inhibitor; oral; Drug: Physician's choice chemotherapy

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wahroonga, New South Wales, Australia, 2076
      • Sydney Adventist Hospital
    • Wahroonga, New South Wales, Australia, 2076
      • Dr Anil Arora
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Misericordiae Health Services Brisbane Limited
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
    • Adelaide, South Australia, Australia, 5000
      • Adelaide Eye and Retina Centre
    • Adelaide, South Australia, Australia, 5000
      • Adelaide Cardiology
    • Norwood, South Australia, Australia, 5067
      • Thomas and Delaney Optometrists
    • Toorak Gardens, South Australia, Australia, 5065
      • Burnside War Memorial Hospital
  • Victoria
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, A-6020
      • Innsbruck Medical University
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Gent, Belgium, 9000
    • Ghent University Hospital
  • Gent, Belgium, 9000
    • University Hospital Gent
  • Liege, Belgium, 4000
    • CHR de la Citadelle
  • Namur, Belgium, 5000
    • Clinique et Maternite Sainte-Elisabeth Namur
  • Wilrijk, Belgium, 2610
    • Sint-Augustinus
  • Luxembourg
    • Libramont, Luxembourg, Belgium, 6800
      • Centre Hospitalier de l'Ardenne
    • Libramont, Luxembourg, Belgium, 6800
      • Private practice Ophthalmology
  • Vlaams-brabant
    • Leuven, Vlaams-brabant, Belgium, 3000
      • University Hospital Leuven
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Centre
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • British Columbia Cancer Agency - Vancouver Centre
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • CancerCare Manitoba
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Center, Department of Oncology
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Jewish General Hospital
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Teaching Hospital Hradec Kralove
  • Olomouc, Czechia, 775 20
    • Fakultni nemocnice Olomouc
  • Ostrava - Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Ostrava - Poruba, Czechia, 70852
    • Fakultni Nemocnice Ostrava
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultni Nemocnice Ostrava
  • Prague, Czechia, 120 00
    • General University Hospital in Prague
  • Prague 2, Czechia, 128 08
    • General University Hospital in Prague
• Denmark
  • Herlev, Denmark, 02730
    • Herlev Hospital Onkologisk AFD
  • Kobenhavn o, Denmark, 2100
    • Region Hovedstadens Apotek
  • Kobenhavn o, Denmark, 2100
    • Rigshospitalet
  • København Ø, Denmark, 2100
    • Ojenklinikken 2061
  • København Ø, Denmark, 2100
    • Radiologisk Afdeling 2023
  • North Jutland
    • Aalborg, North Jutland, Denmark, 9000
      • Aalborg University Hospital
    • Aalborg, North Jutland, Denmark, 9000
      • Aalborg Sygehus Apotek
• Finland
  • Tampere, Finland, FI-33251
    • Tampere University Hospital
• France
  • Besancon, France, 25000
    • Chu Jean Minjoz
  • LYON Cedex 08, France, 69373
    • Centre Léon Bérard
  • Lille, France, 59000
    • Centre Oscar Lambret
  • Lille, France, 59000
    • Hôpital privé La Louvière
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
  • Marseille, France, 13008
    • Centre Paradis Monticelli
  • Marseille Cedex 09, France, 13273
    • Institut Paoli Calmettes - Departement d'Oncologie Medicale
  • Montferrier S/lez, France, 34980
    • Centre d'Ophtalmologie du LEZ Centre Medical Les Roques
  • Montpellier CEDEX 5, France, 34298
    • Institut régional du Cancer Montpellier
  • NANTES Cedex 2, France, 44277
    • l'Hôpital privé du Confluent SAS
  • Nantes, France, 44000
    • Cabinet Liberal du Dr Xavier Zanlonghi
  • Nantes, France, 44000
    • Clinique Sourdille
  • Paris, France, 75012
    • Centre d'Investigations Cliniques 1423
  • Paris Cedex 15, France, 75908
    • Hôpital Européen Georges Pompidou
  • Plerin, France, 22190
    • Centre Investigateur CARIO - HPCA
  • Saint-Herblain Cedex, France, 44805
    • Institut de Cancerologie de I'Ouest - Rene Gauducheau
  • Villejuif Cedex, France, 94805
    • Institut Gustave Roussy
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin
  • Freiburg, Germany, 79106
    • Universitaetsklinik Freiburg
  • Greifswald, Germany, 17475
    • Frauenheilkunde und Geburtshilfe
  • Heidelberg, Germany, 69120
    • NCT Nationales Centrum für Tumorerkrankungen Heidelberg
  • Baden-wuerttemberg
    • Tuebingen, Baden-wuerttemberg, Germany, 72076
      • Universitaets-Brustzentrum
  • Baden-wurttemberg
    • Ulm, Baden-wurttemberg, Germany, 89075
      • Universitätsfrauenklinik Ulm
  • Bavaria
    • Munich, Bavaria, Germany, 81675
      • Klinikum Rechts der Isar
  • Hessen
    • Kassel, Hessen, Germany, 34125
      • Klinik für Frauenheilkunde und Geburtshilfe
  • North Rhine-westphalia
    • Essen, North Rhine-westphalia, Germany, 45136
      • Kliniken Essen-Mitte
  • North-rhine Westphalia
    • Bonn, North-rhine Westphalia, Germany, 53127
      • Universitätsklinikum Bonn
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Uni Carl Gustav Carus
  • Schleswig-holstein
    • Kiel, Schleswig-holstein, Germany, 24105
      • Universitätsklinikum Schleswig-Holstein
• Hungary
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1134
    • Magyar Honvedseg Egeszsegugyi Kozpont
  • Budapest, Hungary, 1062
    • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
  • Budapest, Hungary, 1088
    • Semmelweis Egyetem AOK Szemeszeti Klinika
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly
  • Budapest, Hungary, 1122
    • Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
  • Gyor-moson-sopron
    • Gyor, Gyor-moson-sopron, Hungary, 9023
      • Euromedic Diagnostics Magyarorszag Kft.
    • Gyor, Gyor-moson-sopron, Hungary, 9024
      • Petz Aladar Korhaz Kardiologiai Osztaly
    • Gyor, Gyor-moson-sopron, Hungary, 9024
      • Petz Aladar Korhaz Szemeszeti Osztaly
• Ireland
  • Dublin 8
    • Dublin, Dublin 8, Ireland
      • St James's Hospital
• Italy
  • Bologna, Italy, 40138
    • SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi
  • Bologna, Italy, 40138
    • Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi
  • Brescia, Italy, 25123
    • Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica
  • Brescia, Italy, 25125
    • Spedali Civili di Brescia
  • Catania, Italy, 95216
    • Azienda Ospedaliera Cannizzaro
  • Milano, Italy, 20132
    • Ospedale San Raffaele - Unita Operativa di Oculistica
  • Milano, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica
  • Milano, Italy, 20141
    • Istituto Europeo Oncologico
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica
  • Napoli, Italy, 80131
    • Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico
  • Napoli, Italy, 80131
    • Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze
  • Napoli, Italy, 80131
    • Universita degli Studi Federico II di Napoli Oncologia Medica
  • Pordenone, Italy, 33081
    • Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Croci - Oculistica
  • Ravenna, Italy, 48121
    • Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia
  • Roma, Italy, 00168
    • Policlinico Agostino Gemelli
  • Roma, Italy, 00161
    • Dipartimento Organi di Senso
  • Roma, Italy, 00168
    • Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Istituto Clinico Humanitas
  • Pordenone
    • Aviano, Pordenone, Italy, 33081
      • Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C
  • RM
    • Roma, RM, Italy, 00144
      • Istituto Nazionale Tumori Regina Elena - Oncologia Medica A
  • Ravenna
    • Faenza, Ravenna, Italy, 48018
      • Ospedale Civile degli Infermi - Servizio di Oculistica
    • Faenza, Ravenna, Italy, 48018
      • Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica
    • Lugo, Ravenna, Italy, 48022
      • Ospedale Umberto I - Unita Operativa di Oncologia
  • Rome
    • Roma, Rome, Italy, 00155
      • Policlinico Umberto I - Università Sapienza
    • Roma, Rome, Italy, 00189
      • Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen, Medical Oncology
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Centre
  • Noord-holland
    • Amsterdam, Noord-holland, Netherlands, 1150 AZ
      • Academic Medical Center (AMC)
• Norway
  • Oslo, Norway, 0264
    • Aleris
  • Oslo, Norway, 0379
    • Avd. for gynekologisk kreft, Radiumhospitalet
  • Oslo, Norway, 0450
    • Oslo Universitetssykehus HF
• Poland
  • Warsaw, Poland, 04-141
    • Centralny Szpital Kliniczny MON
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic Barcelona
  • Barcelona, Spain, 08017
    • Ophthalmology at Instituto Oftalmologico Integral
  • Barcelona, Spain, 08970
    • Hospital de Sant Joan Despi Moises Broggi
  • Cordoba, Spain, 14004
    • Cardiology at Consulta de Cardiologia
  • Cordoba, Spain, 14012
    • Centro Medico Sanitas Ressalta
  • Cordoba, Spain, 14012
    • Instituto de Oftalmologia y Hospital La Arruzafa
  • Cordoba, Spain, 14012
    • Radiology at Centro Medico Sanitas Ressalta
  • L'Hospitalet de Llobregat, Spain, 08907
    • Radiology at Hospital Univeristari de Bellvitge
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal
  • Palma de Mallorca, Spain, 07198
    • Hospital Son Llàtzer
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46009
    • Fundacion IVO-Instituto Valenciano de Oncologia
  • Valencia, Spain, 46026
    • Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
      • Hospital Duran i Reynals
  • Castilla LA Mancha
    • Córdoba, Castilla LA Mancha, Spain, 14004
      • Hospital Universitario Reina Sofía/ Provincial
  • Guipuzcoa
    • Anoeta, Guipuzcoa, Spain, 20270
      • Centro de Salud Anoeta
    • San Sebastian, Guipuzcoa, Spain, 20014
      • Hospital Universitario Donostia
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset
  • Uppsala, Sweden, 751 85
    • Onkologkliniken Akademiska Sjukhuset
• United Kingdom
  • London, United Kingdom, SW3 6JJ
    • Royal Marsden NHS Foundation Trust
  • London, United Kingdom, W1G 8PP
    • The Harley Street Clinic
  • London, United Kingdom, W1G 9QN
    • London Eye Diagnostic Centre
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation Trust
  • England
    • London, England, United Kingdom, W1G 6AD
      • Sarah Cannon Research Institute UK
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • University of Nottingham
    • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
      • Nottingham University Hospitals NHS Trust
  • Surrey
    • Ashtead, Surrey, United Kingdom, KT21 2SB
      • Ashtead Hospital
    • Epsom, Surrey, United Kingdom, KT18 7LX
      • The Clock House Medical Practice
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Royal Marsden NHS Foundation Trust
  • Sutton
    • North Cheam, Sutton, United Kingdom, SM3 9Dw
      • St. Anthony's Hospital
  • WEST Midlands
    • Birmingham, WEST Midlands, United Kingdom, B18 7QH
      • City Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants, Ltd.
    • Phoenix, Arizona, United States, 85004
      • University of Arizona Cancer Center
    • Scottsdale, Arizona, United States, 85258
      • Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90095
      • Doris Stein Research Center Building
    • Los Angeles, California, United States, 90033
      • USC/Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90033
      • LAC & USC Medical Center
    • Los Angeles, California, United States, 90033
      • USC Healthcare Consultation Center 1
    • Los Angeles, California, United States, 90033
      • USC Healthcare Consultation Center 2
    • Los Angeles, California, United States, 90095
      • Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles, Hematology-Oncology Clinic
    • Newport Beach, California, United States, 92663
      • Gynecologic Oncology Associates
    • Orange, California, United States, 92868
      • University of California, Irvine/UC Irvine Health
    • Santa Monica, California, United States, 90404
      • UCLA Hematology/Oncology Clinic - Santa Monica
    • Valencia, California, United States, 91355
      • UCLA Hematology Oncology Clinic Santa Clarita
    • Westlake Village, California, United States, 91361
      • UCLA Hematology - Oncology Clinic - Westlake Village
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Lions Eye Institute
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver, University of Colorado Cancer Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale-New Haven
  • Florida
    • Maitland, Florida, United States, 32751
      • Eye Physicians of Central Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital Cancer Institute
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Orlando, Florida, United States, 32835
      • Eye Physicians of Central
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
    • Wellington, Florida, United States, 33414
      • Florida Cancer Specialists
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Gynecologic Oncology
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital And Health Care Center, Inc.
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Cancer Care
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Gynecology Oncology
    • Indianapolis, Indiana, United States, 46290
      • Associated Vitreoretinal and Uveitis Consultants
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Greenebaum Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston (OCB)
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48201
      • Kresge Eye Institute
    • Farmington Hills, Michigan, United States, 48334
      • Karmanos Cancer Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
    • Saint Louis, Missouri, United States, 63110
      • Center for Advanced Medicine
    • Saint Louis, Missouri, United States, 63110
      • Center for Clinical Studies
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • University of New Mexico Cancer Center
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center - Einstein Center for Cancer Care
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Centennial Women's Health
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center, Green Medical Arts Pavilion
    • New York, New York, United States, 10022
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Center
    • Cleveland, Ohio, United States, 44111
      • Fairview Hospital Moll Pavilion Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic-Main Campus
    • Columbus, Ohio, United States, 43210
      • OSU Wexner Medical Center
    • Columbus, Ohio, United States, 43212
      • Stefanie Spielman Comprehensive Breast Cancer
    • Columbus, Ohio, United States, 43210
      • James Cancer Hospital & Solove Research Institute
    • Hilliard, Ohio, United States, 43026
      • OSU Gynecologic Oncology at Mill Run
    • Mayfield Heights, Ohio, United States, 44124
      • Hillcrest Hospital
    • West Chester, Ohio, United States, 45219
      • University of Cincinnati Physicians Company
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Dean McGee Eye Institute
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center(clinic location)
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Jeanes Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75235
      • Parkland Health and Hospital System
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center-Clements University Hospital
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center-Zale Lipshy University Hospital
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEK162	Drug: MEK162, MEK inhibitor; oral; multiple dose, single schedule
Active Comparator: Physician's choice chemotherapy	Drug: Physician's choice chemotherapy; Patients will receive one of the following chemotherapies as determined by the physician: Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule); Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule); Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)	PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (>=) 5 millimeter (mm). Appearance of new lesions >=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.	From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time from randomization to death due to any cause. Participants who were alive at the data cutoff date were censored for overall survival at their last contact date.	From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)	ORR was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR) (responders). CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 mm, PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease.	From randomization until disease progression or death (up to 24 months)
Duration of Response (DOR)	DOR was defined as the time from first radiographic evidence of response to the earliest documented progression date or death due to any cause, and was calculated on responders only. Responders with no PD or death date or subsequent anticancer therapy by the data cutoff date, were censored for DOR at their last radiological assessment. Responders who received subsequent anticancer therapy prior to PD or death were censored at their last radiological assessment prior to initiation of subsequent anticancer therapy.	From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
Disease Control Rate (DCR)	Disease control rate was defined as percentage of participants with disease control. Disease control was defined as a best response of CR or PR, or stable disease (SD) documented at Week 24 or later. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm, and PR is defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Non-target lesions must be non-progressive disease. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters on study.	Week 24
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	From the first dose of study intervention until 30 days after the last dose (up to 9 years)
Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03	Number of participants with shifts from normal Baseline values (Grade 0) to abnormal post-baseline values on-study (shift to greater than or equal to Grade 3) were reported as per NCI-CTCAE, v4.03 graded from Grade 1 to 5. Grade 1: Mild; asymptomatic/ mild symptoms; clinical/diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local/noninvasive intervention indicated. Grade 3: Severe/medically significant but not immediately life-threatening; hospitalization/prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Shifts in lab parameter from Grade 0 to 3, Grade 0 to 4 and Grade 0 to Low 3 and 4 and Grade 0 to High 3 and 4 (for parameters total hemoglobin, lymphocytes, white blood cells, calcium, magnesium, potassium, and sodium) were reported.	From the first dose of study intervention until 30 days after the last dose (up to 9 years)
Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)	EORTC QLQ-C30 is a 30-item cancer-specific instrument that assesses participant reported outcomes, consisting of 5 functional scales, 3 symptoms scales, a global health status/quality of life (QOL) scale, and 6 single-item scales. The global health status/QOL scale has 7 possible scores of responses (1=very poor to 7=excellent). All other items have 4 possible scores (1=not at all, 2=a little, 3=quite a bit, 4=very much). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for global health status/QOL and functional scales, and 0 being the best and 100 being the worst for symptoms scales. In this study, global health status/QOL scale score was identified as the primary patient-reported outcome variable of interest. Physical functioning, emotional functioning, and social functioning scale scores were considered as secondary. Higher scores indicate better quality of life.	Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28)	EORTC QLQ-OV28 contains 28 items which assess a comprehensive range of relevant issues: abdominal/gastrointestinal (GI) symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal/menopausal symptoms, body image, attitude to disease/treatment and sexual functioning. The score for each domain and component score were scaled from 0 (minimum) to 100 (maximum). Higher scores indicate lower quality of life except for sexual functioning where higher scores indicate better quality of life.	Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)	FACT/GOG-NTX questionnaire consists of questions for dimensions related to physical, social, emotional, and functional well-being which contains 11 items, with responses scored on a Likert scale from 0 (not at all) to 4 (very much) designed to capture the symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The summed scores of each item were reverted into standardized scores ranging from 0 to 44, with a higher score indicating a lower level of neurological toxicity and less effect on quality of life (ie, higher scores indicate better quality of life). The trial outcome index consists of two subscales from the FACT-G: Physical Well Being (7 items) and Functional Well Being (7 items), plus the Cervix Cancer-specific subscale (15 items). Each item in the trial outcome index scored using a 5-point scale (0=not at all to 4=very much). The summed scores of each item were reverted into standardized scores ranging from 0 to 116. Higher scores indicate better quality of life.	Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
Predose Plasma Concentration (Ctrough) of MEK162	Ctrough of MEK162 is defined as the predose plasma concentration of MEK162. Ctrough of MEK162 was observed directly from data.	Predose on Study Days 1, 57, and 113.
Maximum Observed Plasma Concentration (Cmax) of MEK162	Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data.	2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2013
• Primary Completion (Actual): January 20, 2016
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: May 6, 2013
• First Submitted That Met QC Criteria: May 7, 2013
• First Posted (Estimated): May 9, 2013

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: ARRAY-162-311; C4211003 (Other Identifier: Alias Study Number); 2013-000277-72 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.