Breast Cancer Clinical Trial
A Study of MEK162 vs. Physician’s Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 168 Locations for this study
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85020, United States
Scottsdale Arizona, 85258, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Los Angeles California, 90095, United States
Newport Beach California, 92663, United States
Orange California, 92868, United States
Santa Monica California, 90404, United States
Valencia California, 91355, United States
Westlake Village California, 91361, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Maitland Florida, 32751, United States
Orlando Florida, 32803, United States
Orlando Florida, 32804, United States
Orlando Florida, 32835, United States
Tampa Florida, 33612, United States
Wellington Florida, 33414, United States
West Palm Beach Florida, 33401, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60637, United States
Indianapolis Indiana, 46260, United States
Indianapolis Indiana, 46260, United States
Indianapolis Indiana, 46260, United States
Indianapolis Indiana, 46260, United States
Indianapolis Indiana, 46290, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Farmington Hills Michigan, 48334, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Billings Montana, 59101, United States
Albuquerque New Mexico, 87106, United States
Albuquerque New Mexico, 87109, United States
Bronx New York, 10461, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Bronx New York, 10467, United States
New York New York, 10022, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43212, United States
Hilliard Ohio, 43026, United States
Mayfield Heights Ohio, 44124, United States
West Chester Ohio, 45219, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73104, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19111, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75235, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22903, United States
Wahroonga New South Wales, 2076, Australia
Wahroonga New South Wales, 2076, Australia
Westmead New South Wales, 2145, Australia
South Brisbane Queensland, 4101, Australia
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Adelaide South Australia, 5000, Australia
Norwood South Australia, 5067, Australia
Toorak Gardens South Australia, 5065, Australia
St Albans Victoria, 3021, Australia
Nedlands Western Australia, 6009, Australia
Innsbruck Tirol, A-602, Austria
Libramont Luxembourg, 6800, Belgium
Libramont Luxembourg, 6800, Belgium
Leuven Vlaams-brabant, 3000, Belgium
Brussels , 1200, Belgium
Gent , 9000, Belgium
Gent , 9000, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V5Z 4, Canada
Winnipeg Manitoba, R2H 2, Canada
Hamilton Ontario, L8V 5, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H3T 1, Canada
Hradec Kralove , 500 0, Czechia
Olomouc , 775 2, Czechia
Ostrava - Poruba , 708 5, Czechia
Ostrava - Poruba , 70852, Czechia
Ostrava-Poruba , 708 5, Czechia
Prague 2 , 128 0, Czechia
Prague , 120 0, Czechia
Aalborg North Jutland, 9000, Denmark
Aalborg North Jutland, 9000, Denmark
Herlev , 02730, Denmark
Kobenhavn o , 2100, Denmark
Kobenhavn o , 2100, Denmark
København Ø , 2100, Denmark
København Ø , 2100, Denmark
Tampere , FI-33, Finland
Besancon , 25000, France
Lille , 59000, France
Lille , 59000, France
LYON Cedex 08 , 69373, France
Lyon , 69003, France
Marseille Cedex 09 , 13273, France
Marseille , 13008, France
Montferrier S/lez , 34980, France
Montpellier CEDEX 5 , 34298, France
NANTES Cedex 2 , 44277, France
Nantes , 44000, France
Nantes , 44000, France
Paris Cedex 15 , 75908, France
Paris , 75012, France
Plerin , 22190, France
Saint-Herblain Cedex , 44805, France
Villejuif Cedex , 94805, France
Tuebingen Baden-wuerttemberg, 72076, Germany
Ulm Baden-wurttemberg, 89075, Germany
Munich Bavaria, 81675, Germany
Kassel Hessen, 34125, Germany
Essen North Rhine-westphalia, 45136, Germany
Bonn North-rhine Westphalia, 53127, Germany
Dresden Saxony, 01307, Germany
Kiel Schleswig-holstein, 24105, Germany
Berlin , 13353, Germany
Freiburg , 79106, Germany
Greifswald , 17475, Germany
Heidelberg , 69120, Germany
Gyor Gyor-moson-sopron, 9023, Hungary
Gyor Gyor-moson-sopron, 9024, Hungary
Gyor Gyor-moson-sopron, 9024, Hungary
Budapest , 1062, Hungary
Budapest , 1062, Hungary
Budapest , 1088, Hungary
Budapest , 1122, Hungary
Budapest , 1122, Hungary
Budapest , 1122, Hungary
Budapest , 1134, Hungary
Dublin Dublin 8, , Ireland
Rozzano Milano, 20089, Italy
Aviano Pordenone, 33081, Italy
Faenza Ravenna, 48018, Italy
Faenza Ravenna, 48018, Italy
Lugo Ravenna, 48022, Italy
Roma RM, 00144, Italy
Roma Rome, 00155, Italy
Roma Rome, 00189, Italy
Bologna , 40138, Italy
Bologna , 40138, Italy
Brescia , 25123, Italy
Brescia , 25125, Italy
Catania , 95216, Italy
Milano , 20132, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Napoli , 80131, Italy
Napoli , 80131, Italy
Napoli , 80131, Italy
Pordenone , 33081, Italy
Ravenna , 48121, Italy
Ravenna , 48121, Italy
Roma , 00161, Italy
Roma , 00168, Italy
Roma , 00168, Italy
Amsterdam Noord-holland, 1150 , Netherlands
Groningen , 9713 , Netherlands
Maastricht , 6229 , Netherlands
Oslo , 0264, Norway
Oslo , 0379, Norway
Oslo , 0450, Norway
Warsaw , 04-14, Poland
L'Hospitalet de Llobregat Barcelona, 08908, Spain
Córdoba Castilla LA Mancha, 14004, Spain
Anoeta Guipuzcoa, 20270, Spain
San Sebastian Guipuzcoa, 20014, Spain
Barcelona , 08017, Spain
Barcelona , 08036, Spain
Barcelona , 08970, Spain
Cordoba , 14004, Spain
Cordoba , 14012, Spain
Cordoba , 14012, Spain
Cordoba , 14012, Spain
L'Hospitalet de Llobregat , 08907, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Palma de Mallorca , 07198, Spain
Sevilla , 41009, Spain
Toledo , 45004, Spain
Valencia , 46009, Spain
Valencia , 46026, Spain
Stockholm , 171 7, Sweden
Uppsala , 751 8, Sweden
London England, W1G 6, United Kingdom
Nottingham Nottinghamshire, NG5 1, United Kingdom
Nottingham Nottinghamshire, NG7 2, United Kingdom
Ashtead Surrey, KT21 , United Kingdom
Epsom Surrey, KT18 , United Kingdom
Sutton Surrey, SM2 5, United Kingdom
North Cheam Sutton, SM3 9, United Kingdom
Birmingham WEST Midlands, B18 7, United Kingdom
London , SW3 6, United Kingdom
London , W1G 8, United Kingdom
London , W1G 9, United Kingdom
Manchester , M20 4, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.