Conditions: Low-grade Serous Ovarian Cancer Low-grade Serous Fallopian Tube Cancer Low-grade Serous Peritoneal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 341
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: MEK162, MEK inhibitor; oral intervention 2: Physician's choice chemotherapy
Intervention descriptions: intervention 1: multiple dose, single schedule intervention 2: 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)

Protocol document: