NCT01849874|TerminatedPhase 3ResultsDMC

Study Stopped

Per recommendation of the DMC, enrollment into the study was discontinued in April 2016 after the planned interim efficacy analysis showed the hazard ratio for PFS crossed the predefined futility boundary.

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

Pfizer ClinicalTrials.gov

Compare

3 other identifiers

ARRAY-162-311C42110032013-000277-72

Study Type

interventional

Target

341

Locations

18 countries

Sites

225

Timeline

RegisteredMay 2013

StartedJun 2013

CompletionAug 2022

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

341

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jun 2013

Longer than P75 for phase_3

Geographic Reach

18 countries

225 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.2 years study duration

First Submitted

Initial submission to the registry

May 6, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2013

Completed

2 months until next milestone

Study Start

First participant enrolled

June 27, 2013

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2016

Completed

5.2 years until next milestone

Results Posted

Study results publicly available

March 30, 2021

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed

Last Updated

October 30, 2023

Status Verified

October 1, 2023

Enrollment Period

2.6 years

First QC Date

May 6, 2013

Results QC Date

March 3, 2021

Last Update Submit

October 26, 2023

Conditions

Low-grade Serous Ovarian Cancer Low-grade Serous Fallopian Tube Cancer Low-grade Serous Peritoneal Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (11)

Overall Survival (OS)
From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)
Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1)
From randomization until disease progression or death (up to 24 months)
Duration of Response (DOR)
From the first radiographic evidence of response to the first documentation of PD or death, for censored participants at their last radiological assessment (up to 24 months)
Disease Control Rate (DCR)
Week 24
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
From the first dose of study intervention until 30 days after the last dose (up to 9 years)
+6 more secondary outcomes

Study Arms (2)

MEK162

EXPERIMENTAL

Drug: MEK162, MEK inhibitor; oral

Physician's choice chemotherapy

ACTIVE COMPARATOR

Drug: Physician's choice chemotherapy

Interventions

MEK162, MEK inhibitor; oralDRUG

multiple dose, single schedule

MEK162

Physician's choice chemotherapyDRUG

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)

Physician's choice chemotherapy

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (226)

University of Arizona Cancer Center

Phoenix, Arizona, 85004, United States

Location

Associated Retina Consultants, Ltd.

Phoenix, Arizona, 85020, United States

Location

Oncology Research Associates, PLLC d/b/a Pinnacle Oncology Hematology

Scottsdale, Arizona, 85258, United States

Location

Keck Hospital of USC