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



Status:Active, not recruiting
Conditions:Ovarian Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:June 2013
End Date:September 2019

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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.


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.
We found this trial at
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Billings, Montana 59101
Phone: 406-435-7482
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
Phone: 706-721-8978
Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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Aurora, Colorado 80045
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Baltimore, Maryland
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Boston, Massachusetts
Phone: 617-582-7738
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Columbus, Ohio 43214
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Indianapolis, Indiana 46202
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Iowa City, Iowa 52242
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Irvine, California 92697
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