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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Array BioPharma
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
First received: May 6, 2013
Last updated: April 15, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Low-grade Serous Ovarian Cancer
Low-grade Serous Fallopian Tube Cancer
Low-grade Serous Peritoneal Cancer
Drug: MEK162, MEK inhibitor; oral
Drug: Physician's choice chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased progression-free survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of overall survival, objective response rate, duration of response and disease control rate. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug vs. physician's choice of selected chemotherapies in terms of adverse events and clinical laboratory tests. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Assess the effect on global health status of study drug vs. physician's choice of selected chemotherapies in terms of quality-of-life questionnaires. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Characterize the plasma pharmacokinetics (PK) of study drug in terms of plasma concentration-time profiles and model-based PK parameters. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849874

Contact: Array BioPharma Clinical Trial Call Center 303-381-6604

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United States, Arizona
Phoenix, Arizona, United States
Contact: Kelli Williamson    602-406-6689    kelli.williamson@dignityhealth.org   
Scottsdale, Arizona, United States
Contact: Deana Garrett, RN    480-860-5000 ext 244    dgarrett@azpoh.com   
United States, California
Irvine, California, United States
Contact: Anita Wallick    714-456-6191    wallicka@uci.edu   
Los Angeles, California, United States
Contact: Kristy Watkins    323-865-0452    kristy.watkins@med.usc.edu   
Los Angeles, California, United States
Contact: Suzanne Branch    310-794-3102    sbranch@mednet.ucla.edu   
Newport Beach, California, United States
United States, Colorado
Aurora, Colorado, United States
Contact: Sidney McIntosh    720-848-0681    sidney.mcintosh@ucdenver.edu   
United States, Connecticut
New Haven, Connecticut, United States
Contact: Lisa Baker    203-785-6398    lisa.baker@yale.edu   
United States, Florida
Orlando, Florida, United States
Contact: Debbie Sams    407-303-7354    deborah.sams@flhosp.org   
Tampa, Florida, United States
Contact: Jennifer Tiemann    813-745-7272    jennifer.tiemann@moffitt.org   
West Palm Beach, Florida, United States
Contact: Jennifer Bar-Nur, RN, BSN    561-366-4100 ext 4759    jbar-nur@flcancer.com   
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact    706-721-8978      
United States, Illinois
Chicago, Illinois, United States
Contact: Tiffany Parks    773-702-2643    tparks@bsd.uchicago.edu   
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Indianapolis, Indiana, United States
Contact: Rachele Willett, RN    317-415-6751      
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Iowa City, Iowa, United States
Contact: Sharon Stockman    319-356-2015    sharon-stockman@uiowa.edu   
United States, Maryland
Baltimore, Maryland, United States
Contact: Jagdish Shetty    410-328-7680    jshetty@umm.edu   
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Boston, Massachusetts, United States
Contact: Tina Atkinson    617-724-4800    tatkinson1@partners.org   
Boston, Massachusetts, United States
Contact: Christin Whalen    617-582-7738    Christin_whalen@dfci.harvard.edu   
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Detroit, Michigan, United States
Contact: Marianne Garcia    313-576-8394    garciam@karmanos.org   
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Contact: Kathy Estkowski    616-685-5156    estkowk@mercyhealth.com   
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St. Louis, Missouri, United States
Contact: Lynne Lippmann    314-362-1760    lippmannl@wudosis.wustl.edu   
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Billings, Montana, United States
Contact: Judy Miller    406-435-7482    jmiller4@billingsclinic.org   
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Albuquerque, New Mexico, United States
Contact: Sheri Westgate    505-925-0383    swestgate@salud.unm.edu   
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Bronx, New York, United States
Contact: Eileen Burke    718-405-8082    eburke@montefiore.org   
New York, New York, United States
Contact: Rachel Grisham, MD    646-888-4653    grishamr@mskcc.org   
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Cincinnati, Ohio, United States
Contact: Michael Blakeman    513-584-5044    michael.blakeman@uc.edu   
Cleveland, Ohio, United States
Contact: Donna White    216-444-3414    whited11@ccf.org   
Cleveland, Ohio, United States
Contact: Susan Eaton    216-844-4710    susan.eaton@uhhospitals.org   
Columbus, Ohio, United States
Contact: Anna Adairs    614-293-7582    anna.adairs@osumc.edu   
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Oklahoma City, Oklahoma, United States
Contact: Deborah Wright, RN    405-271-8777    Deborah-Wright@ouhsc.edu   
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Philadelphia, Pennsylvania, United States
Contact: Kristin Padavic    215-728-5715    kristin.padavic-shaller@fccc.edu   
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Contact: Carol Kagemann    412-641-2588    kagemannca@upmc.edu   
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Dallas, Texas, United States
Contact: Isabel Villalobos, MS    214-648-7010    isabel.villalobos@utsouthwestern.edu   
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Contact: Misty Woodall    713-792-2763    mwoodall@mdanderson.org   
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Charlottesville, Virginia, United States
Contact: Heather Lothamer    434-924-9924    hll5y@virginia.edu   
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Calgary, Alberta, Canada
Contact: Leela Pillay    403-521-3016    leela.pillay@albertahealthservices.ca   
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Vancouver, British Columbia, Canada
Contact: Paulo Paralejas    604-877-6000 ext 3223    pparalejas@bccancer.bc.ca   
Canada, Manitoba
Winnipeg, Manitoba, Canada
Contact: Laurel Johnston    204-235-3125    laurel.johnston@cancercare.mb.ca   
Canada, Ontario
Hamilton, Ontario, Canada
Contact: Hal Hirte    905-387-9495      
Toronto, Ontario, Canada
Contact: Valerie Bowering    416-946-2818    valerie.bowering@uhn.ca   
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Montreal, Quebec, Canada
Contact: Penny Chipman    514-398-8307    penny.chipman@mcgill.ca   
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Contact: Nathalie Grenier    514-412-7605    nathalie.grenier.chum@ssss.gouv.qc.ca   
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Sherbrooke, Quebec, Canada
Contact: Annie Bourbonnais    819-346-1110 ext 12890    abourbonnais.chus@ssss.gouv.qc.ca   
Czech Republic
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Brno, Czech Republic
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Tampere, Finland
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University of Bonn - Department of Obstetrics and Gynecology Recruiting
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Erlangen, Germany
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University Hospital of Frankfurt Recruiting
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Universitatsmedizin Gottingen Recruiting
Gottingen, Germany
Uni-Medizin Greifswald Recruiting
Greifswald, Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany
NCT - Gynecological Oncology Section - University Hospital Recruiting
Heidelberg, Germany
Jena University Hospital - Department of Gynecology and Obstetrics Recruiting
Jena, Germany
Klinikum Kassel Recruiting
Kassel, Germany
Studienzentrale Gynakologische Onkologie Recruiting
Kiel, Germany
UniversitatsKlinikum Schleswlg-Holstein Recruiting
Lubeck, Germany
University Hospital of Giessen and Marburg Recruiting
Marburg, Germany
Technical University Munich Recruiting
Munich, Germany
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Tubingen, Germany
University Hopsital of Ulm Recruiting
Ulm, Germany
Hungarian Defense Forces Medical Centre Recruiting
Budapest, Hungary
National Institute of Oncology Recruiting
Budapest, Hungary
Semmelweis University Recruiting
Budapest, Hungary
Aladar Petz County Teaching Hospital Recruiting
Gyor, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Recruiting
Miskolc, Hungary
Josa Andras Oktatokorhaz Recruiting
Nyiregyhaza, Hungary
St James University Hospital Recruiting
Dublin, Ireland
Centro Riferimento Oncologico Recruiting
Aviano, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale Recruiting
Bari, Italy
University Hospital Consortorium Policlinico di Bari Recruiting
Bari, Italy
AOU Bologna Recruiting
Bologna, Italy
Divisione di Ostetricia e Ginecologia Recruiting
Brescia, Italy
Azienda Ospedaliera Cannizzaro Recruiting
Catania, Italy
Hospital of Faenza Recruiting
Faenza, Italy
Unita Operativa di Oncologia Recruiting
Faenza, Italy
National Cancer Institute Milan Recruiting
Milan, Italy
Ospedale Niguarda Ca' Granda Recruiting
Milan, Italy
Instituto Europeo Oncologico Recruiting
Milano, Italy
A.O.U. Federico II Recruiting
Naples, Italy
Istituto Nazionale Tumori di Napoli Recruiting
Naples, Italy
Clinica Ostetrica e Ginecologica, Universita di Pisa Recruiting
Pisa, Italy
Agostino Gemelli Teaching Hospital Recruiting
Roma, Italy
Policlinico Umberto I, Sapienza Recruiting
Roma, Italy
Regina Elena Recruiting
Roma, Italy
Centre Hospitalier Emile Mayrisch Recruiting
Esch-sur-Alzette, Luxembourg
AMC Recruiting
Amsterdam, Netherlands
University Medical Center Recruiting
Groningen, Netherlands
Maastricht University Medical Center+ Recruiting
Maastricht, Netherlands
Haukland University Hospital Recruiting
Bergen, Norway
Norwegian Radium Hospital Recruiting
Oslo, Norway
University Hospital of the 'K. Marcinkowski' Medical University Recruiting
Poznan, Poland
SPSK 2, Pomeranian Medical University Recruiting
Szczecin, Poland
Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON Recruiting
Warszawa, Poland
Hosptial Nuestra Senora de Sonsoles Recruiting
Avila, Spain
Hosptial Clinic de Barcelona Recruiting
Barcelona, Spain
Hospital Moises Broggi Recruiting
Barcelona, Spain
Hospital Duran i Reynals. Insitut Catala Oncologia Recruiting
Catalonia, Spain
Hosptial Universitario Reina Sofia Recruiting
Cordoba, Spain
Hospital 12 de Octubre, Madrid Recruiting
Madrid, Spain
Hospital Ramon y Cajal Recruiting
Madrid, Spain
Carlos Haya Hospital Recruiting
Malaga, Spain
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain
Hospital Son Llatzer Recruiting
Palma de Mallorca, Spain
Hosptial Universitario Donostia Recruiting
San Sebastian, Spain
Complejo Hospitalario Recruiting
Santiago de Compostela, Spain
Hospital Univeritario Virgen Macarena Recruiting
Sevilla, Spain
Hospital Virgen de la Salud Recruiting
Toledo, Spain
The Valencian Institute of Oncology Recruiting
Valencia, Spain
Karolinska University Hospital Recruiting
Stockholm, Sweden
Kliniska provningar Recruiting
Uppsala, Sweden
United Kingdom
City Hospital Recruiting
Birmingham, United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom
Sarah Cannon Research UK Recruiting
London, United Kingdom
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Array BioPharma
Study Director: Array BioPharma 303-381-6604
  More Information

Additional Information:
Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01849874     History of Changes
Other Study ID Numbers: ARRAY-162-311  2013-000277-72 
Study First Received: May 6, 2013
Last Updated: April 15, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Hungary: National Institute of Pharmacy
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Finland: Finnish Medicines Agency
Italy: The Italian Medicines Agency
Spain: Spanish Agency of Medicines
Czech Republic: State Institute for Drug Control
Luxembourg: Ministère de la Santé
Denmark: Danish Health and Medicines Authority
Netherlands: Ministry of Health, Welfare and Sport
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Sweden: Medical Products Agency
Ireland: Irish Medicines Board
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Peritoneal Neoplasms
Abdominal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Peritoneal Diseases

ClinicalTrials.gov processed this record on May 04, 2016