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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01849874
First received: May 6, 2013
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
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 2017 (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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
United States, California
Irvine, California, United States
Los Angeles, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
United States, Georgia
Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Iowa City, Iowa, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Billings, Montana, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
United States, Ohio
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Virginia
Charlottesville, Virginia, United States
Australia
Royal Adelaide Hospital
Adelaide, Australia
Western Health
Footscray, Australia
Sir Charles Gairdner Hospital
Nedlands, Australia
Mater Adult Hospital
South Brisbane, Australia
Sydney Adventist Hospital
Sydney, Australia
Burnside War Memorial Hospital
Toorak Gardens, Australia
Westmead Hospital
Westmead, Australia
Austria
University Clinic Innsbruck
Innsbruck, Austria
AKH Vienna
Vienna, Austria
Belgium
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium
Antwerp University Hospital
Edegem, Belgium
University Hospital Gent
Gent, Belgium
University Hospital Leuven
Leuven, Belgium
Centre Hospitalier de l' Ardenne
Libramont, Belgium
CHC Saint-Joseph
Liege, Belgium
CHR Citadelle
Liege, Belgium
Clinique Ste-Elisabeth
Namur, Belgium
Sint-Augustinus
Wilrijk, Belgium
Canada, Alberta
Calgary, Alberta, Canada
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Ontario
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Czech Republic
Masaryk Mamorial Cancer Institute
Brno, Czech Republic
Teaching Hospital Hradec Kralove
Hradec Kralove, Czech Republic
University Hospital
Olomouc, Czech Republic
Fakulni Nemocnice Ostrava
Ostrava-Poruba, Czech Republic
General University Hospital
Prague, Czech Republic
Hospital Na Bulovce, Institute of Radiation Oncology
Prague, Czech Republic
Denmark
University Hospital
Alborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Department of Oncology
Harlev, Denmark
Finland
Tampere University Hospital
Tampere, Finland
France
Institut de Cancerologie de I'ouest Paul Papin
Angers, France
CHU Jean Minjoz
Besancon, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Institut Paoli Calmettes
Marseille, France
ICM
Montpellier, France
ICO Gauducheau
Nantes Saint-Herblain, France
Centre Catherine de Sienne
Nentes, France
Hopital Europeen Georges Pompidou, rue Leblanc
Paris, France
Hopital Tenon
Paris, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Hopitaux Universitaires de Strasbourg
Strasbourg, France
Institut Gustave Roussy
Villejuif, France
Germany
University Medical Center Aachen
Aachen, Germany
Charite Campus Virchow Klinikum - Frauenklinik
Berlin, Germany
University of Bonn - Department of Obstetrics and Gynecology
Bonn, Germany
Universitatsklinikum Carl Gustav Carus
Dresden, Germany
Frauenklinik University Hospital Erlangen
Erlangen, Germany
Kliniken Essen-Mitte, Evang. Huyssens Stiftung
Essen, Germany
University Hospital
Essen, Germany
University Hospital of Frankfurt
Frankfurt, Germany
University Clinic
Freiburg, Germany
Universitatsmedizin Gottingen
Gottingen, Germany
Uni-Medizin Greifswald
Greifswald, Germany
Medizinische Hochschule Hannover
Hannover, Germany
NCT - Gynecological Oncology Section - University Hospital
Heidelberg, Germany
Jena University Hospital - Department of Gynecology and Obstetrics
Jena, Germany
Klinikum Kassel
Kassel, Germany
Studienzentrale Gynakologische Onkologie
Kiel, Germany
UniversitatsKlinikum Schleswlg-Holstein
Lubeck, Germany
University Hospital of Giessen and Marburg
Marburg, Germany
Technical University Munich
Munich, Germany
Universitats-Frauenklinik
Tubingen, Germany
University Hopsital of Ulm
Ulm, Germany
Hungary
Hungarian Defense Forces Medical Centre
Budapest, Hungary
National Institute of Oncology
Budapest, Hungary
Semmelweis University
Budapest, Hungary
Aladar Petz County Teaching Hospital
Gyor, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato
Miskolc, Hungary
Josa Andras Oktatokorhaz
Nyiregyhaza, Hungary
Ireland
St James University Hospital
Dublin, Ireland
Italy
Centro Riferimento Oncologico
Aviano, Italy
Azienda Ospedaliero-Universitaria Policlinico Consorziale
Bari, Italy
University Hospital Consortorium Policlinico di Bari
Bari, Italy
AOU Bologna
Bologna, Italy
Divisione di Ostetricia e Ginecologia
Brescia, Italy
Azienda Ospedaliera Cannizzaro
Catania, Italy
Hospital of Faenza
Faenza, Italy
Unita Operativa di Oncologia
Faenza, Italy
Instituto Europeo Oncologico
Milano, Italy
National Cancer Institute Milan
Milan, Italy
Ospedale Niguarda Ca' Granda
Milan, Italy
A.O.U. Federico II
Naples, Italy
Istituto Nazionale Tumori di Napoli
Naples, Italy
Clinica Ostetrica e Ginecologica, Universita di Pisa
Pisa, Italy
Agostino Gemelli Teaching Hospital
Roma, Italy
Policlinico Umberto I, Sapienza
Roma, Italy
Regina Elena
Roma, Italy
Luxembourg
Centre Hospitalier Emile Mayrisch
Esch-sur-Alzette, Luxembourg
Netherlands
AMC
Amsterdam, Netherlands
University Medical Center
Groningen, Netherlands
Maastricht University Medical Center+
Maastricht, Netherlands
Norway
Haukland University Hospital
Bergen, Norway
Norwegian Radium Hospital
Oslo, Norway
Poland
University Hospital of the 'K. Marcinkowski' Medical University
Poznan, Poland
SPSK 2, Pomeranian Medical University
Szczecin, Poland
Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON
Warszawa, Poland
Spain
Hosptial Nuestra Senora de Sonsoles
Avila, Spain
Hospital Moises Broggi
Barcelona, Spain
Hosptial Clinic de Barcelona
Barcelona, Spain
Hospital Duran i Reynals. Insitut Catala Oncologia
Catalonia, Spain
Hosptial Universitario Reina Sofia
Cordoba, Spain
Hospital 12 de Octubre, Madrid
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Carlos Haya Hospital
Malaga, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Son Llatzer
Palma de Mallorca, Spain
Hosptial Universitario Donostia
San Sebastian, Spain
Complejo Hospitalario
Santiago de Compostela, Spain
Hospital Univeritario Virgen Macarena
Sevilla, Spain
Hospital Virgen de la Salud
Toledo, Spain
The Valencian Institute of Oncology
Valencia, Spain
Sweden
Karolinska University Hospital
Stockholm, Sweden
Kliniska provningar
Uppsala, Sweden
United Kingdom
City Hospital
Birmingham, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Sarah Cannon Research UK
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Sponsors and Collaborators
Array BioPharma
Investigators
Study Director: Array BioPharma 303-381-6604
  More 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: July 27, 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:
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on September 23, 2016