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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT01849874
• Date of registration: 06/05/2013
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
• Scientific title: 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
• Date of first enrolment: June 27, 2013
• Target sample size: 341
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT01849874
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, China, Czech Republic, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Pfizer Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Key Inclusion Criteria:

- 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.

Key Exclusion Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Low-grade Serous Fallopian Tube Cancer

Low-grade Serous Peritoneal Cancer

Low-grade Serous Ovarian Cancer

Intervention(s)

Drug: Physician's choice chemotherapy

Drug: MEK162, MEK inhibitor; oral

Primary Outcome(s)

Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) [Time Frame: 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 Outcome(s)

Number of Participants With Shift Greater Than or Equal to Grade 3 From Baseline in Laboratory Parameter Values Based on National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.03 [Time Frame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)]

Objective Response Rate Per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (RECIST V1.1) [Time Frame: From randomization until disease progression or death (up to 24 months)]

Overall Survival (OS) [Time Frame: From randomization date to the date of death, for censored participants at their last contact date (up to 24 months)]

Duration of Response (DOR) [Time Frame: 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)]

Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module (QLQ-OV28) [Time Frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit]

Predose Plasma Concentration (Ctrough) of MEK162 [Time Frame: Predose on Study Days 1, 57, and 113.]

Disease Control Rate (DCR) [Time Frame: Week 24]

Maximum Observed Plasma Concentration (Cmax) of MEK162 [Time Frame: 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.]

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: From the first dose of study intervention until 30 days after the last dose (up to 9 years)]

Quality of Life Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) [Time Frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit]

Quality of Life Per Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-NTX) [Time Frame: Screening, every 8 weeks from randomization for the first 72 weeks (while on treatment), treatment discontinuation visit, 30-day safety follow-up visit]

Secondary ID(s)

2013-000277-72

ARRAY-162-311

C4211003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/03/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01849874