The Milo Study (Mek Inhibitor In Low-Grade Serous Ovarian Cancer): A Multinational, Randomized, Open-Label Phase 3 Study Of Mek162 Vs. Physician’S Choice Of Chemotherapy In Patients With Recurrent Or Persistent Low-Grade Serous Carcinomas Of The Ovary, Fallopian Tube Or Primary Peritoneum
Posted Date: Mar 10, 2014
- Investigator: Eric Eisenhauer
- Specialties: Cancer, Gynecologic Oncology
- Type of Study: Drug
This clinical research study is sponsored by the biopharmaceutical company named Array BioPharma Inc. (the Sponsor). The purpose of this study is to find out if the study medicine, MEK162, is safe and has beneficial effects in people who have cancer of the ovary, fallopian tube or primary peritoneum, or ovarian cancer. If you agree to join this study, you may get either MEK162 or another chemotherapy drug chosen by your study doctor. If you get MEK162, the study may also test how your body breaks down MEK162. You will be given either MEK162 or one of three other chemotherapy medicines: either liposomal doxorubicin, paclitaxel or topotecan. If you do not get MEK162, your study doctor will choose which of the three chemotherapy drugs might be best for you. MEK162 is an investigational drug being developed by Array BioPharma for treating advanced/metastatic cancers, including your cancer. “Investigational” means that the drug being tested has not been approved for use by the United States Food and Drug Administration (FDA). MEK162 is a medication that is taken by mouth twice a day, once in the morning and once in the evening. Liposomal doxorubicin is approved by the FDA for the treatment of ovarian cancer. Liposomal doxorubicin is a medication that is given through a needle into your vein (IV), over approximately a 1 hour period. In this study, liposomal doxorubicin will be given on Day 1 of every 28-day cycle. Paclitaxel (also called Taxol®) is approved by the FDA for the treatment of advanced ovarian cancer. Paclitaxel is a medication that is given through a needle into your vein (IV) over approximately a 1 hour period. In this study, paclitaxel will be given on Days 1, 8 and 15 of every 28 day cycle. You may also receive premedication to reduce the likelihood of an allergic reaction occurring when you receive your paclitaxel. Topotecan is approved by the FDA for the treatment of ovarian cancer. Topotecan is a medication that is given through a needle into your vein (IV) over approximately a 30-minute period. In this study, topotecan will be given on Days 1 through 5 of every 21 day cycle. Approximately 300 patients will join the study at 150 centers around the world. Patients must be 18 years and older to participate in this study.
You Have Been Asked To Consider Taking Part In This Study Because You Have Cancer Of The Ovary, Fallopian Tube Or Primary Peritoneum That Has Not Responded To Standard Cancer Treatments.
Gynecologic Oncology, Oncology, Ovarian Cancer, Persistent, Recurrent
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