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 July 2014 by Array BioPharma
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01849874
First received: May 6, 2013
Last updated: July 3, 2014
Last verified: July 2014
  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. Approximately 300 patients from North America, Europe and Asia Pacific 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:
  • Demonstrate superior efficacy of study drug vs. physician's choice of selected chemotherapies in terms of increased overall survival. [ Time Frame: 6 years post last patient randomized ] [ Designated as safety issue: No ]
  • Obtain additional estimates of the efficacy of study drug vs. physician's choice of selected chemotherapies in terms of objective response rate, duration of response and disease control rate. [ Time Frame: 3 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: 300
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Phoenix, Arizona, United States
Contact: Kelli Williamson    602-406-6689    kelli.williamson@dignityhealth.org   
Recruiting
Scottsdale, Arizona, United States
Contact: Deana Garrett, RN    480-860-5000 ext 244    dgarrett@azpoh.com   
United States, California
Recruiting
Irvine, California, United States
Contact: Anita Wallick    714-456-6191    wallicka@uci.edu   
Recruiting
Los Angeles, California, United States
Contact: Kristy Watkins    323-865-0452    kristy.watkins@med.usc.edu   
Recruiting
Los Angeles, California, United States
Contact: Suzanne Branch    310-794-3102    sbranch@mednet.ucla.edu   
Recruiting
Newport Beach, California, United States
Contact: Katrina Lopez    949-642-5165    katrinal@gynoncology.com   
United States, Colorado
Recruiting
Aurora, Colorado, United States
Contact: Sidney McIntosh    720-848-0681    sidney.mcintosh@ucdenver.edu   
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
Contact: Lisa Baker    203-785-6398    lisa.baker@yale.edu   
United States, Florida
Recruiting
Orlando, Florida, United States
Contact: Debbie Sams    407-303-7354    deborah.sams@flhosp.org   
Recruiting
Tampa, Florida, United States
Contact: Jennifer Tiemann    813-745-7272    jennifer.tiemann@moffitt.org   
United States, Illinois
Recruiting
Chicago, Illinois, United States
Contact: Tiffany Parks    773-702-2643    tparks@bsd.uchicago.edu   
United States, Iowa
Recruiting
Iowa City, Iowa, United States
Contact: Sharon Stockman    319-356-2015    sharon-stockman@uiowa.edu   
United States, Maryland
Recruiting
Baltimore, Maryland, United States
Contact: Jagdish Shetty    410-328-7680    jshetty@umm.edu   
United States, Michigan
Recruiting
Detroit, Michigan, United States
Contact: Marianne Garcia    313-576-8394    garciam@karmanos.org   
Recruiting
Grand Rapids, Michigan, United States
Contact: Kathy Estkowski    616-685-5156    estkowk@mercyhealth.com   
United States, Missouri
Recruiting
St. Louis, Missouri, United States
Contact: Lynne Lippmann    314-362-1760    lippmannl@wudosis.wustl.edu   
United States, Montana
Recruiting
Billings, Montana, United States
Contact: Judy Miller    406-435-7482    jmiller4@billingsclinic.org   
United States, New Mexico
Recruiting
Albuquerque, New Mexico, United States
Contact: Sheri Westgate    505-925-0383    swestgate@salud.unm.edu   
United States, New York
Recruiting
Bronx, New York, United States
Contact: Eileen Burke    718-405-8082    eburke@montefiore.org   
Recruiting
New York, New York, United States
Contact: Rachel Grisham, MD    646-888-4653    grishamr@mskcc.org   
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Contact: Michael Blakeman    513-584-5044    michael.blakeman@uc.edu   
Recruiting
Cleveland, Ohio, United States
Contact: Donna White    216-444-3414    whited11@ccf.org   
Recruiting
Cleveland, Ohio, United States
Contact: Susan Eaton    216-844-4710    susan.eaton@uhhospitals.org   
Recruiting
Columbus, Ohio, United States
Contact: Anna Adairs    614-293-7582    anna.adairs@osumc.edu   
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
Contact: Deborah Wright, RN    405-271-8777    Deborah-Wright@ouhsc.edu   
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States
Contact: Kristin Padavic    215-728-5715    kristin.padavic-shaller@fccc.edu   
Recruiting
Pittsburg, Pennsylvania, United States
Contact: Carol Kagemann    412-641-2588    kagemannca@upmc.edu   
United States, Texas
Recruiting
Dallas, Texas, United States
Contact: Isabel Villalobos, MS    214-648-7010    isabel.villalobos@utsouthwestern.edu   
Recruiting
Houston, Texas, United States
Contact: Misty Woodall    713-792-2763    mwoodall@mdanderson.org   
United States, Virginia
Recruiting
Charlottesville, Virginia, United States
Contact: Heather Lothamer    434-924-9924    hll5y@virginia.edu   
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Western Health Recruiting
Footscray, Australia
Mater Adult Hospital Recruiting
South Brisbane, Australia
Burnside War Memorial Hospital Recruiting
Toorak Gardens, Australia
Westmead Hospital Recruiting
Westmead, Australia
Austria
University Clinic Innsbruck Recruiting
Innsbruck, Austria
Belgium
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium
University Hospital Leuven Recruiting
Leuven, Belgium
Centre Hospitalier de l' Ardenne Recruiting
Libramont, Belgium
CHC Saint-Joseph Recruiting
Liege, Belgium
Clinique Ste-Elisabeth Recruiting
Namur, Belgium
Sint-Augustinus Recruiting
Wilrijk, Belgium
Canada, Alberta
Recruiting
Calgary, Alberta, Canada
Contact: Leela Pillay    403-521-3016    leela.pillay@albertahealthservices.ca   
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
Contact: Paulo Paralejas    604-877-6000 ext 3223    pparalejas@bccancer.bc.ca   
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada
Contact: Laurel Johnston    204-235-3125    laurel.johnston@cancercare.mb.ca   
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada
Contact: Hal Hirte    905-387-9495      
Recruiting
Toronto, Ontario, Canada
Contact: Valerie Bowering    416-946-2818    valerie.bowering@uhn.ca   
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Contact: Penny Chipman    514-398-8307    penny.chipman@mcgill.ca   
Recruiting
Montreal, Quebec, Canada
Contact: Nathalie Grenier    514-412-7605    nathalie.grenier.chum@ssss.gouv.qc.ca   
Czech Republic
Masaryk Mamorial Cancer Institute Recruiting
Brno, Czech Republic
University Hospital Recruiting
Olomouc, Czech Republic
Fakulni Nemocnice Ostrava Recruiting
Ostrava-Poruba, Czech Republic
Denmark
University Hospital Recruiting
Alborg, Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark
Finland
Tampere University Hospital Recruiting
Tampere, Finland
Hungary
National Institute of Oncology Recruiting
Budapest, Hungary
Semmelweis University Recruiting
Budapest, Hungary
Hungarian Defense Forces Medical Centre Recruiting
Budapest, Hungary
Aladar Petz County Teaching Hospital Recruiting
Gyor, Hungary
Josa Andras Oktatokorhaz Recruiting
Nyiregyhaza, Hungary
Italy
Unita Operativa di Oncologia Recruiting
Faenza, Italy
Instituto Europeo Oncologico Recruiting
Milano, Italy
Istituto Nazionale Tumori di Napoli Recruiting
Naples, Italy
Agostino Gemelli Teaching Hospital Recruiting
Roma, Italy
Regina Elena Recruiting
Roma, Italy
Luxembourg
Centre Hospitalier Emile Mayrisch Recruiting
Esch-sur-Alzette, Luxembourg
Netherlands
University Medical Center Recruiting
Groningen, Netherlands
Poland
SPSK 2, Pomeranian Medical University Recruiting
Szczecin, Poland
Spain
Hosptial Nuestra Senora de Sonsoles Recruiting
Avila, Spain
Hospital Moises Broggi Recruiting
Barcelona, Spain
Hosptial Clinic de Barcelona Recruiting
Barcelona, Spain
Hospital Duran i Reynals. Insitut Catala Oncologia Recruiting
Catalonia, Spain
Hosptial Universitario Reina Sofia Recruiting
Cordoba, Spain
Hospital Ramon y Cajal Recruiting
Madrid, Spain
Hospital Son Llatzer Recruiting
Palma de Mallorca, Spain
Hosptial Universitario Donostia Recruiting
San Sebastian, Spain
The Valencian Institute of Oncology Recruiting
Valencia, Spain
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
  More Information

Additional Information:
No publications provided

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 3, 2014
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on July 22, 2014