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    Summary
    EudraCT Number:2013-000277-72
    Sponsor's Protocol Code Number:ARRAY-162-311
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-12-09
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNorway - NOMA
    A.2EudraCT number2013-000277-72
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study evaluating the efficacy of an investigational compound (MEK162) in adult female patients with a specific type of ovarian, fallopian tube or peritoneum cancer
    A.3.2Name or abbreviated title of the trial where available
    The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer)
    A.4.1Sponsor's protocol code numberARRAY-162-311
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01849874
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorArray BioPharma Inc. (a wholly owned subsidiary of Pfizer Inc)
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportArray BioPharma Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArray BioPharma Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Centre
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.6E-mailClinicalTrials.gov_Inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namebinimetinib
    D.3.2Product code MEK162
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBINIMETINIB
    D.3.9.1CAS number 606143-89-9
    D.3.9.2Current sponsor codeMEK162
    D.3.9.4EV Substance CodeSUB179942
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Recurrent or persistent low-grade serous (LGS)
    carcinomas of the ovary, fallopian tube or primary peritoneum
    E.1.1.1Medical condition in easily understood language
    Recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube or primary peritoneum
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether treatment with MEK162 prolongs Progression-free survival as compared to physician’s choice of selected chemotherapies (liposomal doxorubicin, paclitaxel and topotecan) in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube or primary peritoneum
    E.2.2Secondary objectives of the trial
    Obtain additional estimates of the efficacy (including overall survival [OS]) of MEK162 vs. physician’s choice of selected chemotherapies
    • Characterize the safety profile of MEK162 vs. physician’s choice of selected chemotherapies
    • Assess the effect on global health status of MEK162 vs. physician’s choice of selected chemotherapies
    • Characterize the plasma pharmacokinetics (PK) of MEK162 in this patient population
    • During the crossover period, after failure of physician’s choice chemotherapy in the randomized period:
    o Assess the efficacy of MEK162
    o Characterize the safety profile of MEK162
    o Assess the effect on global health status of MEK162
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    •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.
    •Other protocol-defined inclusion criteria exist.
    E.4Principal exclusion criteria
    •History or current evidence of retinal vein occlusion (RVO), or current risk factors for RVO.
    •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.
    •Other protocol-defined exclusion criteria exist.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-free survival as determined by the blinded independent central review (BICR). The local Investigator assessments will be used as supportive analyses.

    As of Protocol Version 6 (date 15 March 2017), BICR review of tumor assessments will no longer be performed; tumor assessments in both the randomized and crossover periods will be conducted by the study sites according to institutional standards. Results of tumor assessments will be retained in patient files only and no longer be entered into the eCRFs.
    As of Protocol Version 6 (date 15 March 2017), all patients will return for a 30-Day Safety Follow-up Visit approximately 30 days after the last dose of study drug for safety. After completion of this visit, all patients will end their participation in the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Tumor assessments will be performed every 8 weeks from
    randomization for the first 72 weeks, then every 12 weeks while the
    patient is receiving study drug treatment, irrespective of the days of study drug administration. Patients who have locally
    determined Progressive Disease (PD) confirmed by the BICR will discontinue study drug and cease tumor assessments. Patients who discontinue study drug for reasons other than PD per BICR will continue to have tumor assessments every 8 weeks from randomization for the first 72 weeks, then every 12 weeks for the remainder of the study until one of the following (whichever occurs first): locally determined PD is confirmed by the BICR, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death.
    E.5.2Secondary end point(s)
    Overall survival
    • Objective response rate (ORR) as defined by the Response Evaluation Criteria in Solid Tumorso Assessment by the QOL questionnaires EORTC QLQ-C30, EORTC QLQ-OV28 and FACT/GOG-NTX (RECIST), Version 1.1
    • Duration of response (DOR)
    • Disease control rate (DCR), defined as having achieved a best response of complete response (CR) or partial response (PR), or stable disease (SD) documented at Week 24 or later
    • Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03
    • Changes in clinical laboratory parameters
    • Assessment by the quality-of-life (QOL) questionnaires European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-OV28 and Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG)-Neurotoxicity (NTX)
    • Plasma concentration-time profiles and model-based PK parameters of MEK162 (and metabolite AR00426032, if feasible) in a subset of the patients randomized to receive MEK162
    • During the crossover period, after failure of physician’s choice chemotherapy in the randomized period:
    o Progression-free survival as determined by local Investigator assessments
    o Objective response rate as defined by RECIST, Version 1.1
    o Duration of response
    o Incidence and severity of AEs, graded according to the NCI CTCAE, Version 4.03
    o Changes in clinical laboratory parameterso Assessment by the QOL questionnaires EORTC QLQ-C30, EORTC QLQ-OV28 and FACT/GOG-NTX
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival: All patients will be followed for survival until withdrawal of consent, lost to follow-up or death; or until the study ends.
    ORR, DOR, DCR: Tumor assessments will be performed every 8 weeks from randomization for the first 72 weeks, then every 12 weeks for the remainder of the study
    Safety:Continuously while on study drug and for 30 days after the last dose of study drug.
    Patient Reported Outcomes: The EORTC QLQ-C30, EORTC QLQ-OV28 and FACT-GOG/NTX questionnaires will be completed within 7 days prior to randomization; every 8 weeks from randomization for the first 72 weeks; at the Treatment Discontinuation Visit;and at the 30-Day Safety Follow-up Visit.
    PK:Pharmacokinetic samples will be drawn predose and
    2 hours ± 10 minutes postdose on Days 1, 57 and 113.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA106
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    United States
    Austria
    Belgium
    Denmark
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Luxembourg
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    United Kingdom
    Czechia
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 360
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All patients will be transitioned to standard of care therapy according to institutional standards and will be treated at the discretion of the Investigator
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation European Network of Gynaecological Oncological Trial Groups (ENGOT)
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-23
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