Clinical trial NCT01849874: A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Low-grade Serous Ovarian Cancer
Low-grade Serous Fallopian Tube Cancer
Low-grade Serous Peritoneal Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-05-09
Enrollment: 341
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: 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:
measure: Overall Survival (OS)
timeFrame: From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
measure: Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
timeFrame: From randomization until disease progression or death (up to 24 months)
measure: Duration of Response (DOR)
timeFrame: 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)
measure: Disease Control Rate (DCR)
timeFrame: Week 24
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)
measure: 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
timeFrame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)
measure: Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30)
timeFrame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
measure: Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28)
timeFrame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
measure: Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX)
timeFrame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit
measure: Predose Plasma Concentration (Ctrough) of MEK162
timeFrame: Predose on Study Days 1, 57, and 113.
measure: Maximum Observed Plasma Concentration (Cmax) of MEK162
timeFrame: 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology
state: Arizona
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC Healthcare Consultation Center 1
state: California
city: Los Angeles
country: United States
facility: USC Healthcare Consultation Center 2
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Admin.Office/Study Supplies Mailing Address: UCLA Medicine Hematology-Oncology
state: California
city: Los Angeles
country: United States
facility: Doris Stein Research Center Building
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles, Hematology-Oncology Clinic
state: California
city: Newport Beach
country: United States
facility: Gynecologic Oncology Associates
state: California
city: Orange
country: United States
facility: University of California, Irvine/UC Irvine Health
state: California
city: Santa Monica
country: United States
facility: UCLA Hematology/Oncology Clinic - Santa Monica
state: California
city: Valencia
country: United States
facility: UCLA Hematology Oncology Clinic Santa Clarita
state: California
city: Westlake Village
country: United States
facility: UCLA Hematology - Oncology Clinic - Westlake Village
state: California
city: Aurora
country: United States
facility: Rocky Mountain Lions Eye Institute
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver, University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale-New Haven
state: Connecticut
city: Maitland
country: United States
facility: Eye Physicians of Central Florida
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Eye Physicians of Central
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Wellington
country: United States
facility: Florida Cancer Specialists
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University Cancer Center
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Cancer Care
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Gynecologic Oncology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Gynecology Oncology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital and Health Care Center, Inc.
state: Indiana
city: Indianapolis
country: United States
facility: Associated Vitreoretinal and Uveitis Consultants
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Cancer Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston (OCB)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Center For Clinical Studies
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Einstein Center for Cancer Care
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center - Centennial Women's Health
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center, Green Medical Arts Pavilion
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital Moll Pavilion Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic-Main Campus
state: Ohio
city: Columbus
country: United States
facility: James Cancer Hospital & Solove Research Institute
state: Ohio
city: Columbus
country: United States
facility: OSU Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Stefanie Spielman Comprehensive Breast Cancer
state: Ohio
city: Hilliard
country: United States
facility: OSU Gynecologic Oncology at Mill Run
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
city: West Chester
country: United States
facility: University of Cincinnati Physicians Company
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center(clinic location)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jeanes Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Zale Lipshy University Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-Clements University Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Wahroonga
country: Australia
facility: Dr Anil Arora
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Health Services Brisbane Limited
state: Queensland
city: Adelaide
country: Australia
facility: Adelaide Cardiology
state: South Australia
city: Adelaide
country: Australia
facility: Adelaide Eye and Retina Centre
state: South Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Norwood
country: Australia
facility: Thomas and Delaney Optometrists
state: South Australia
city: Toorak Gardens
country: Australia
facility: Burnside War Memorial Hospital
state: South Australia
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Innsbruck Medical University
state: Tirol
city: Libramont
country: Belgium
facility: Centre Hospitalier de l'ardenne
state: Luxembourg
city: Libramont
country: Belgium
facility: Private practice Ophthalmology
state: Luxembourg
city: Leuven
country: Belgium
facility: University Hospital Leuven
state: Vlaams-brabant
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Gent
country: Belgium
facility: Ghent University Hospital
city: Gent
country: Belgium
facility: University Hospital Gent
city: Liege
country: Belgium
facility: CHR de la Citadelle
city: Namur
country: Belgium
facility: Clinique et Maternite Sainte-Elisabeth Namur
city: Wilrijk
country: Belgium
facility: Sint-Augustinus
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency - Vancouver Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: Juravinski Cancer Center, Department of Oncology
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (Chum) - Hopital Notre-Dame
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Teaching Hospital Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava - Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Ostrava - Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Prague 2
country: Czechia
facility: General University Hospital in Prague
city: Prague
country: Czechia
facility: General University Hospital in Prague
city: Aalborg
country: Denmark
facility: Aalborg Sygehus Apotek
state: North Jutland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Jutland
city: Herlev
country: Denmark
facility: Herlev Hospital Onkologisk AFD
city: Kobenhavn o
country: Denmark
facility: Region Hovedstadens Apotek
city: Kobenhavn o
country: Denmark
facility: Rigshospitalet
city: København Ø
country: Denmark
facility: Ojenklinikken 2061
city: København Ø
country: Denmark
facility: Radiologisk Afdeling 2023
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Hopital Prive La Louviere
city: LYON Cedex 08
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille Cedex 09
country: France
facility: Institut Paoli Calmettes - Departement d'Oncologie Medicale
city: Marseille
country: France
facility: Centre Paradis Monticelli
city: Montferrier S/lez
country: France
facility: Centre d'Ophtalmologie du LEZ Centre Medical Les Roques
city: Montpellier CEDEX 5
country: France
facility: Institut Regional du Cancer Montpellier
city: NANTES Cedex 2
country: France
facility: L'Hopital Prive du Confluent SAS
city: Nantes
country: France
facility: Cabinet Liberal du Dr Xavier Zanlonghi
city: Nantes
country: France
facility: Clinique Sourdille
city: Paris Cedex 15
country: France
facility: Hopital Europeen Georges Pompidou
city: Paris
country: France
facility: Centre d'Investigations Cliniques 1423
city: Plerin
country: France
facility: Centre Investigateur CARIO - HPCA
city: Saint-Herblain Cedex
country: France
facility: Institut de Cancerologie de I'Ouest - Rene Gauducheau
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Tuebingen
country: Germany
facility: Universitaets-Brustzentrum
state: Baden-wuerttemberg
city: Ulm
country: Germany
facility: Universitätsfrauenklinik Ulm
state: Baden-wurttemberg
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
city: Kassel
country: Germany
facility: Klinik fur Frauenheilkunde und Geburtshilfe
state: Hessen
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
state: North Rhine-westphalia
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: North-rhine Westphalia
city: Dresden
country: Germany
facility: Uni Carl Gustav Carus
state: Saxony
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-holstein
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin
city: Freiburg
country: Germany
facility: Universitaetsklinik Freiburg
city: Greifswald
country: Germany
facility: Frauenheilkunde und Geburtshilfe
city: Heidelberg
country: Germany
facility: NCT Nationales Centrum für Tumorerkrankungen Heidelberg
city: Gyor
country: Hungary
facility: Euromedic Diagnostics Magyarorszag Kft.
state: Gyor-moson-sopron
city: Gyor
country: Hungary
facility: Petz Aladar Korhaz Kardiologiai Osztaly
state: Gyor-moson-sopron
city: Gyor
country: Hungary
facility: Petz Aladar Korhaz Szemeszeti Osztaly
state: Gyor-moson-sopron
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont, Onkologiai Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK Szemeszeti Klinika
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet Kozponti Aneszteziologiai es Intenzivterapias Osztaly
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet, Nogyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Dublin
country: Ireland
facility: St James's Hospital
state: Dublin 8
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - Struttura Operativa Complessa (SOC)- Oncologia Medica C
state: Pordenone
city: Faenza
country: Italy
facility: Ospedale Civile degli Infermi - Servizio di Oculistica
state: Ravenna
city: Faenza
country: Italy
facility: Ospedale Civile degli Infermi - Unita Operativa di Oncologia Medica
state: Ravenna
city: Lugo
country: Italy
facility: Ospedale Umberto I - Unita Operativa di Oncologia
state: Ravenna
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena - Oncologia Medica A
state: RM
city: Roma
country: Italy
facility: Policlinico Umberto I - Università Sapienza
state: Rome
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant' Andrea - Unita Operativa Semplice di Patologia Vitreo-Retinica
state: Rome
city: Bologna
country: Italy
facility: SSD Oncologia Medica Addarii-Zamagni - Policlinico S. Orsola-Malpighi
city: Bologna
country: Italy
facility: Struttura Complessa di Oftalmologia Policlinico S. Orsola-Malpighi
city: Brescia
country: Italy
facility: Spedali Civili di Brescia - Struttura Complessa Clinicizzata - U.O.di Oculistica
city: Brescia
country: Italy
facility: Spedali Civili Di Brescia
city: Catania
country: Italy
facility: Azienda Ospedaliera Cannizzaro
city: Milano
country: Italy
facility: Ospedale San Raffaele - Unita Operativa di Oculistica
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori - SC Oncologia Ginecologica
city: Milano
country: Italy
facility: Istituto Europeo Oncologico
city: Napoli
country: Italy
facility: Azienda Ospedaliera Vincenzo Monaldi di Napoli - U.O.C. di Oculistica
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori di Napoli, "G.Pascale" , Oncologia Medica, Dipartimento Uro-Ginecologico
city: Napoli
country: Italy
facility: Universita degli Studi Federico II di Napoli Dipartimento di Neuroscienze Scienze
city: Napoli
country: Italy
facility: Universita degli Studi Federico II di Napoli Oncologia Medica
city: Pordenone
country: Italy
facility: Azienda Opsedaliera S. Maria Degli Angeli Pordenone-Dipartimento di Chirurgia Specialistica -
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci - Oculistica
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci - Unita Operativa di Oncologia
city: Roma
country: Italy
facility: Dipartimento Organi di Senso
city: Roma
country: Italy
facility: Dipartimento di Scienze Chirurgiche per le Patologie della Testa e del Collo - UOC di Oculistica
city: Roma
country: Italy
facility: Policlinico Agostino Gemelli
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
state: Noord-holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Medical Oncology
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Oslo
country: Norway
facility: Aleris
city: Oslo
country: Norway
facility: Avd. for gynekologisk kreft, Radiumhospitalet
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF
city: Warsaw
country: Poland
facility: Centralny Szpital Kliniczny MON
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
state: Barcelona
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía/ Provincial
state: Castilla LA Mancha
city: Anoeta
country: Spain
facility: Centro de Salud Anoeta
state: Guipuzcoa
city: San Sebastian
country: Spain
facility: Hospital Universitario Donostia
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Ophthalmology at Instituto Oftalmologico Integral
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despi Moises Broggi
city: Cordoba
country: Spain
facility: Cardiology at Consulta de Cardiologia
city: Cordoba
country: Spain
facility: Centro Medico Sanitas Ressalta
city: Cordoba
country: Spain
facility: Instituto de Oftalmologia y Hospital La Arruzafa
city: Cordoba
country: Spain
facility: Radiology at Centro Medico Sanitas Ressalta
city: L'Hospitalet de Llobregat
country: Spain
facility: Radiology at Hospital Univeristari de Bellvitge
city: Madrid
country: Spain
facility: Hospital Ramón Y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Fundacion IVO-Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Ophthalmology at Hospital Universitari i Politecnic La Fe de Valencia
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Onkologkliniken Akademiska Sjukhuset
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
state: England
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: Nottingham
country: United Kingdom
facility: University of Nottingham
state: Nottinghamshire
city: Ashtead
country: United Kingdom
facility: Ashtead Hospital
state: Surrey
city: Epsom
country: United Kingdom
facility: The Clock House Medical Practice
state: Surrey
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
city: North Cheam
country: United Kingdom
facility: St. Anthony's Hospital
state: Sutton
city: Birmingham
country: United Kingdom
facility: City Hospital
state: WEST Midlands
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: The Harley Street Clinic
city: London
country: United Kingdom
facility: London Eye Diagnostic Centre
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.