Trials / Terminated
TerminatedNCT01849874
A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
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 Chemotherapy in Patients With Recurrent or Persistent Low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 341 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Low-grade Serous Ovarian Cancer
- Low-grade Serous Fallopian Tube Cancer
- Low-grade Serous Peritoneal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MEK162, MEK inhibitor; oral | multiple dose, single schedule |
| 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) |
Timeline
- Start date
- 2013-06-27
- Primary completion
- 2016-01-20
- Completion
- 2022-08-23
- First posted
- 2013-05-09
- Last updated
- 2023-10-30
- Results posted
- 2021-03-30
Locations
226 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT01849874. Inclusion in this directory is not an endorsement.