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Terminated PHASE3 INTERVENTIONAL NCT01849874

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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.

Interventions

Name: MEK162, MEK inhibitor; oral

Type: DRUG

Description: multiple dose, single schedule

Name: Physician's choice chemotherapy

Type: DRUG

Description: 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)

Primary Outcomes

Measure: Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

TimeFrame: From randomization until documented progressive disease (PD) or death, whichever occurred first, for censored participants at the date of last adequate tumor assessment (up to 24 months)

Description: PFS was defined as the time from randomization to the earliest documented disease progression date or death due to any cause whichever occurred first. Disease progression was defined as at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of greater than or equal to (\>=) 5 millimeter (mm). Appearance of new lesions \>=10 mm in diameter also constituted PD. If a participant did not have an event at the time of the analysis cutoff or at the start of any new therapy, PFS was censored at the date of last adequate tumor assessment.

Trial Information

NCT ID

NCT01849874

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Pfizer

Last Updated

December 15, 2025