AzTrials
AzTrials

Low-grade Serous Ovarian CancerPhase 3NCT01849874

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

A Phase 3 study testing MEK162, MEK inhibitor; oral and Physician's choice chemotherapy in people with Low-grade Serous Ovarian Cancer and Low-grade Serous Fallopian Tube Cancer, run by Pfizer at 226 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
MEK162, MEK inhibitor; oral and Physician's choice chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
341 participants
Where
226 sitesin 19 countries
Study dates
27 Jun 2013to 23 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

226 sites in 19 countries.

226 sites in 19 countries

United States77 sites

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109

  • Georgia Regents University Cancer Center

    Augusta, Georgia, 30912

  • Rocky Mountain Lions Eye Institute

    Aurora, Colorado, 80045

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Colorado Denver, University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Billings Clinic

    Billings, Montana, 59101

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston (OCB)

    Boston, Massachusetts, 02114

  • University of Virginia

    Charlottesville, Virginia, 22903

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Fairview Hospital Moll Pavilion Cancer Center

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Cleveland Clinic-Main Campus

    Cleveland, Ohio, 44195

  • James Cancer Hospital & Solove Research Institute

    Columbus, Ohio, 43210

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

  • Stefanie Spielman Comprehensive Breast Cancer

    Columbus, Ohio, 43212

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

  • UT Southwestern Medical Center-Zale Lipshy University Hospital

    Dallas, Texas, 75235

  • UT Southwestern Medical Center-Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Kresge Eye Institute

    Detroit, Michigan, 48201

  • Karmanos Cancer Institute

    Farmington Hills, Michigan, 48334

  • OSU Gynecologic Oncology at Mill Run

    Hilliard, Ohio, 43026

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • St. Vincent Cancer Care

    Indianapolis, Indiana, 46260

  • St. Vincent Gynecologic Oncology

    Indianapolis, Indiana, 46260

  • St. Vincent Gynecology Oncology

    Indianapolis, Indiana, 46260

  • St. Vincent Hospital and Health Care Center, Inc.

    Indianapolis, Indiana, 46260

  • Associated Vitreoretinal and Uveitis Consultants

    Indianapolis, Indiana, 46290

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • LAC & USC Medical Center

    Los Angeles, California, 90033

  • USC Healthcare Consultation Center 1

    Los Angeles, California, 90033

  • USC Healthcare Consultation Center 2

    Los Angeles, California, 90033

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology

    Los Angeles, California, 90095

  • Doris Stein Research Center Building

    Los Angeles, California, 90095

  • University of California Los Angeles, Hematology-Oncology Clinic

    Los Angeles, California, 90095

  • Eye Physicians of Central Florida

    Maitland, Florida, 32751

  • Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10022

  • Gynecologic Oncology Associates

    Newport Beach, California, 92663

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Stephenson Cancer Center(clinic location)

    Oklahoma City, Oklahoma, 73104

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of California, Irvine/UC Irvine Health

    Orange, California, 92868

  • Florida Hospital

    Orlando, Florida, 32803

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Eye Physicians of Central

    Orlando, Florida, 32835

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Jeanes Hospital

    Philadelphia, Pennsylvania, 19111

  • University of Arizona Cancer Center

    Phoenix, Arizona, 85004

  • Associated Retina Consultants, Ltd.

    Phoenix, Arizona, 85020

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • UCLA Hematology/Oncology Clinic - Santa Monica

    Santa Monica, California, 90404

  • Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Center For Clinical Studies

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Montefiore Medical Center - Einstein Center for Cancer Care

    The Bronx, New York, 10461

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Montefiore Medical Center - Centennial Women's Health

    The Bronx, New York, 10467

  • Montefiore Medical Center, Green Medical Arts Pavilion

    The Bronx, New York, 10467

  • UCLA Hematology Oncology Clinic Santa Clarita

    Valencia, California, 91355

  • Florida Cancer Specialists

    Wellington, Florida, 33414

  • University of Cincinnati Physicians Company

    West Chester, Ohio, 45219

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • UCLA Hematology - Oncology Clinic - Westlake Village

    Westlake Village, California, 91361

Other trials in United States

Italy26 sites

  • Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C

    Aviano, Pordenone, 33081

  • SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica

    Brescia, 25123

  • Spedali Civili Di Brescia

    Brescia, 25125

  • Azienda Ospedaliera Cannizzaro

    Catania, 95216

  • Ospedale Civile degli Infermi - Servizio di Oculistica

    Faenza, Ravenna, 48018

  • Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica

    Faenza, Ravenna, 48018

  • Ospedale Umberto I - Unita Operativa di Oncologia

    Lugo, Ravenna, 48022

  • Ospedale San Raffaele - Unita Operativa di Oculistica

    Milan, 20132

  • Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica

    Milan, 20133

  • Istituto Europeo Oncologico

    Milan, 20141

  • Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica

    Naples, 80131

  • Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico

    Naples, 80131

  • Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze

    Naples, 80131

  • Universita degli Studi Federico II di Napoli Oncologia Medica

    Naples, 80131

  • Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -

    Pordenone, 33081

  • Ospedale Santa Maria delle Croci - Oculistica

    Ravenna, 48121

  • Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia

    Ravenna, 48121

  • Istituto Nazionale Tumori Regina Elena - Oncologia Medica A

    Roma, RM, 00144

  • Policlinico Umberto I - Università Sapienza

    Roma, ROME, 00155

  • Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica

    Roma, ROME, 00189

  • Dipartimento Organi di Senso

    Roma, 00161

  • Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica

    Roma, 00168

  • Policlinico Agostino Gemelli

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

Spain19 sites

  • Centro de Salud Anoeta

    Anoeta, Guipuzcoa, 20270

  • Ophthalmology at Instituto Oftalmologico Integral

    Barcelona, 08017

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital de Sant Joan Despi Moises Broggi

    Barcelona, 08970

  • Hospital Universitario Reina Sofía/ Provincial

    Córdoba, Castille-La Mancha, 14004

  • Cardiology at Consulta de Cardiologia

    Córdoba, 14004

  • Centro Medico Sanitas Ressalta

    Córdoba, 14012

  • Instituto de Oftalmologia y Hospital La Arruzafa

    Córdoba, 14012

  • Radiology at Centro Medico Sanitas Ressalta

    Córdoba, 14012

  • Hospital Universitario Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Radiology at Hospital Univeristari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital Ramón Y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Son Llatzer

    Palma de Mallorca, 07198

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Fundacion IVO-Instituto Valenciano de Oncologia

    Valencia, 46009

  • Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France17 sites

  • CHU Jean Minjoz

    Besançon, 25000

  • Centre Oscar Lambret

    Lille, 59000

  • Hopital Prive La Louviere

    Lille, 59000

  • Hopital Edouard Herriot

    Lyon, 69003

  • Centre Leon Berard

    Lyon, 69373

  • Centre Paradis Monticelli

    Marseille, 13008

  • Institut Paoli Calmettes - Departement d'Oncologie Medicale

    Marseille, 13273

  • Centre d'Ophtalmologie du LEZ Centre Medical Les Roques

    Montferrier S/lez, 34980

  • Institut Regional du Cancer Montpellier

    Montpellier, 34298

  • Cabinet Liberal du Dr Xavier Zanlonghi

    Nantes, 44000

  • Clinique Sourdille

    Nantes, 44000

  • L'Hopital Prive du Confluent SAS

    Nantes, 44277

  • Centre d'Investigations Cliniques 1423

    Paris, 75012

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Centre Investigateur CARIO - HPCA

    Plérin, 22190

  • Institut de Cancerologie de I'Ouest - Rene Gauducheau

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany12 sites

  • Charité Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Uni Carl Gustav Carus

    Dresden, Saxony, 01307

  • Kliniken Essen-Mitte

    Essen, North Rhine-Westphalia, 45136

  • Universitaetsklinik Freiburg

    Freiburg im Breisgau, 79106

  • Frauenheilkunde und Geburtshilfe

    Greifswald, 17475

  • NCT Nationales Centrum für Tumorerkrankungen Heidelberg

    Heidelberg, 69120

  • Klinik fur Frauenheilkunde und Geburtshilfe

    Kassel, Hesse, 34125

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Schleswig-Holstein, 24105

  • Klinikum rechts der Isar

    Munich, Bavaria, 81675

  • Universitaets-Brustzentrum

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsfrauenklinik Ulm

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

United Kingdom12 sites

  • Ashtead Hospital

    Ashtead, Surrey, KT21 2SB

  • City Hospital

    Birmingham, WEST Midlands, B18 7QH

  • The Clock House Medical Practice

    Epsom, Surrey, KT18 7LX

  • Sarah Cannon Research Institute UK

    London, England, W1G 6AD

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Harley Street Clinic

    London, W1G 8PP

  • London Eye Diagnostic Centre

    London, W1G 9QN

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • St. Anthony's Hospital

    North Cheam, Sutton, SM3 9Dw

  • Nottingham University Hospitals NHS Trust

    Nottingham, Nottinghamshire, NG5 1PB

  • University of Nottingham

    Nottingham, Nottinghamshire, NG7 2UH

  • The Royal Marsden NHS Foundation Trust

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Australia11 sites

  • Adelaide Cardiology

    Adelaide, South Australia, 5000

  • Adelaide Eye and Retina Centre

    Adelaide, South Australia, 5000

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Thomas and Delaney Optometrists

    Norwood, South Australia, 5067

  • Mater Misericordiae Health Services Brisbane Limited

    South Brisbane, Queensland, 4101

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Burnside War Memorial Hospital

    Toorak Gardens, South Australia, 5065

  • Dr Anil Arora

    Wahroonga, New South Wales, 2076

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Hungary10 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly

    Budapest, 1062

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis Egyetem AOK Szemeszeti Klinika

    Budapest, 1088

  • Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly

    Budapest, 1122

  • Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly

    Budapest, 1122

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1134

  • Euromedic Diagnostics Magyarorszag Kft.

    Győr, Győr-Moson-Sopron, 9023

  • Petz Aladar Korhaz Kardiologiai Osztaly

    Győr, Győr-Moson-Sopron, 9024

  • Petz Aladar Korhaz Szemeszeti Osztaly

    Győr, Győr-Moson-Sopron, 9024

Other trials in Hungary

Belgium9 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Ghent University Hospital

    Ghent, 9000

  • University Hospital Gent

    Ghent, 9000

  • University Hospital Leuven

    Leuven, Vlaams-brabant, 3000

  • Centre Hospitalier de l'ardenne

    Libramont, Luxembourg, 6800

  • Private practice Ophthalmology

    Libramont, Luxembourg, 6800

  • CHR de la Citadelle

    Liège, 4000

  • Clinique et Maternite Sainte-Elisabeth Namur

    Namur, 5000

  • Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Canada7 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Juravinski Cancer Center, Department of Oncology

    Hamilton, Ontario, L8V 5C2

  • Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Czechia7 sites

  • Teaching Hospital Hradec Kralove

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 775 20

  • Fakultni nemocnice Ostrava

    Ostrava - Poruba, 708 52

  • Fakultni Nemocnice Ostrava

    Ostrava - Poruba, 70852

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • General University Hospital in Prague

    Prague, 120 00

  • General University Hospital in Prague

    Prague, 128 08

Other trials in Czechia

Denmark7 sites

  • Aalborg Sygehus Apotek

    Aalborg, North Jutland, 9000

  • Aalborg University Hospital

    Aalborg, North Jutland, 9000

  • Herlev Hospital Onkologisk AFD

    Herlev, 02730

  • Ojenklinikken 2061

    København Ø, 2100

  • Radiologisk Afdeling 2023

    København Ø, 2100

  • Region Hovedstadens Apotek

    København Ø, 2100

  • Rigshospitalet

    København Ø, 2100

Other trials in Denmark

Netherlands3 sites

  • Academic Medical Center (AMC)

    Amsterdam, North Holland, 1150 AZ

  • University Medical Center Groningen, Medical Oncology

    Groningen, 9713 GZ

  • Maastricht University Medical Centre

    Maastricht, 6229 HX

Other trials in Netherlands

Norway3 sites

  • Aleris

    Oslo, 0264

  • Avd. for gynekologisk kreft, Radiumhospitalet

    Oslo, 0379

  • Oslo Universitetssykehus HF

    Oslo, 0450

Other trials in Norway

Sweden2 sites

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

  • Onkologkliniken Akademiska Sjukhuset

    Uppsala, 751 85

Other trials in Sweden

Austria1 site

  • Innsbruck Medical University

    Innsbruck, Tyrol, A-6020

Other trials in Austria

Finland1 site

  • Tampere University Hospital

    Tampere, FI-33251

Other trials in Finland

Ireland1 site

  • St James's Hospital

    Dublin, Dublin 8

Other trials in Ireland

Poland1 site

  • Centralny Szpital Kliniczny MON

    Warsaw, 04-141

Other trials in Poland

About this study

Official title: 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.

Being tested
MEK162, MEK inhibitor; oral, Physician's choice chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MEK162, MEK inhibitor; oralDrug

    multiple dose, single schedule

  • Physician's choice chemotherapyDrug

    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)
Study groups in NCT01849874
Study groupRoleWhat they receive
MEK162ExperimentalNot described
Receives: Drug: MEK162, MEK inhibitor; oral
Physician's choice chemotherapyActive comparatorNot described
Receives: Drug: Physician's choice chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (11)

  1. 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.

    Measured: From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)

  2. 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.

    Measured: From randomization until disease progression or death (up to 24 months)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: Week 24

  5. 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.

    Measured: From the first dose of study intervention until 30 days after the last dose (up to 9 years)

  6. 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.

    Measured: From the first dose of study intervention until 30 days after the last dose (up to 9 years)

  7. 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.

    Measured: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit

  8. 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.

    Measured: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit

  9. 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.

    Measured: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit

  10. 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.

    Measured: Predose on Study Days 1, 57, and 113.

  11. Maximum Observed Plasma Concentration (Cmax) of MEK162

    Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data.

    Measured: 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2013 (estimated)
  2. Study start27 Jun 2013
  3. Primary completion20 Jan 2016
  4. Study completion23 Aug 2022

Why it stopped: Per recommendation of the DMC, enrollment into the study was discontinued in April 2016 after the planned interim efficacy analysis showed the hazard ratio for PFS crossed the predefined futility boundary.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
341 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01849874
Sponsor's protocol ID
ARRAY-162-311
Other IDs
C4211003, 2013-000277-72
Status last verified
Oct 2023
First submitted
6 May 2013
Last updated
30 Oct 2023
Data monitoring committee
Yes
Individual data sharing
Yes: 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.

Publications

  • Grisham RN, Vergote I, Banerjee S, Drill E, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Cibula D, Moore KN, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Kristensen G, Clamp A, Farley J, Iyer G, Ray-Coquard I, Monk BJ. Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib versus Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer. Clin Cancer Res. 2023 Oct 13;29(20):4068-4075. doi: 10.1158/1078-0432.CCR-23-0621.

    PubMed 37581616

  • 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.

    PubMed 32822286

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MEK162, MEK inhibitor; oral and Physician's choice chemotherapy in people with Low-grade Serous Ovarian Cancer and Low-grade Serous Fallopian Tube Cancer, run by Pfizer at 226 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 226 sites in United States, Italy, Spain, France, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01849874, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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