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    Summary
    EudraCT Number:2009-015621-36
    Sponsor's Protocol Code Number:EMR200066-004
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-015621-36
    A.3Full title of the trial
    A double-blind, randomized, comparative, multicenter, exploratory, and placebo-controlled Phase II trial of FOLFIRI plus MSC1936369B or placebo with a safety run-in part as second-line treatment of metastatic K Ras mutated colorectal cancer subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial investigating the combination of the experimental drug MEK Inhibitor MSC1936369B in combination with FOLFIRI in Second Line Metastatic Colorectal Cancer (mCRC) with mutated K-Ras.
    A.4.1Sponsor's protocol code numberEMR200066-004
    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 SponsorMerck Serona S.A., Geneva, Switzerland
    B.1.3.4CountrySwitzerland
    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 supportMerck Serona S.A., Geneva, Switzerland
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Serona S.A., Geneva, Switzerland
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post codeD-64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6151 72 5200
    B.5.5Fax number+49 6151 72 2000
    B.5.6E-mailservice@merck.de
    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 nameMEK Inhibitor
    D.3.2Product code MSC1936369B
    D.3.4Pharmaceutical form Capsule
    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 INND.3.8. AS INN
    D.3.9.1CAS number 1236361-78-6
    D.3.9.2Current sponsor codeMSC1936369B
    D.3.9.3Other descriptive nameAS703026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    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 nameMEK Inhibitor
    D.3.2Product code MSC1936369B
    D.3.4Pharmaceutical form Capsule
    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 INND.3.8. AS INN
    D.3.9.1CAS number 1236361-78-6
    D.3.9.2Current sponsor codeMSC1936369B
    D.3.9.3Other descriptive nameAS703026
    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.IMP: 3
    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 nameMEK Inhibitor
    D.3.2Product code MSC1936369B
    D.3.4Pharmaceutical form Capsule
    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 INND.3.8. AS INN
    D.3.9.1CAS number 1236361-78-6
    D.3.9.2Current sponsor codeMSC1936369B
    D.3.9.3Other descriptive nameAS703026
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Colorectal Cancer (second line)
    E.1.1.1Medical condition in easily understood language
    Metastatic Colorectal Cancer (second line)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    Part 1: SAFETY RUN-IN PART

    To determine the Maximum Tolerated Dose (MTD) and the recommended Phase II dose (RP2D) of MSC1936369B combined with FOLFIRI as second-line treatment in subjects with K Ras mutated metastatic colorectal cancer (mCRC).

    Part 2: PHASE II RANDOMIZED PART

    To assess the anti-tumor activity of MSC1936369B combined with FOLFIRI as second-line treatment in subjects with K Ras mutated mCRC in terms of Progression-Free Survival (PFS).
    E.2.2Secondary objectives of the trial
    Part 1: SAFETY RUN-IN PART

    To assess the pharmacokinetics (PK) of MSC1936369B, irinotecan and 5-Fluorouracil (5-FU) (plasma) concentration when combined in subjects with mCRC.

    To explore the anti-tumor activity of MSC1936369B combined with FOLFIRI as second-line treatment for subjects with K Ras mutated mCRC.

    To explore candidate markers for tumor characteristics and predictive of anti-tumor activity.

    To explore circulating markers in serum.

    Part 2: PHASE II RANDOMIZED PART

    To determine safety and tolerability of MSC1936369B combined with FOLFIRI as second-line treatment in subjects with K Ras mutated mCRC.

    To assess the anti-tumor activity in terms of response rate, clinical benefit, overall survival, and time to progression.

    To explore candidate markers for tumor characteristics and predictive of anti-tumor activity.

    To explore circulating markers in serum.

    To assess the pharmacokinetics (PK) of MSC1936369B in subjects with mCRC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically confirmed KRAS mutated colon/rectum cancer.

    Subject’s disease must have progressed during or after a first-line treatment for metastatic disease with oxaliplatin and fluoropyrimidins based chemotherapy with or without bevacizumab.

    Evidence of metastatic measurable disease at trial entry as per Response Evaluation Criteria in Solid Tumors [RECIST v1.0] (at least one measurable lesion). Complete tumor assessment performed within 14 days prior to first trial drug administration.

    Age of subjects at least 18 years.

    Subject has read, understood and given informed consent, fully understands requirements of the trial, and is willing to comply with all trial visits and assessments.

    Women of childbearing potential must have a negative blood pregnancy test at the screening visit. For the purposes of this trial, women of childbearing potential are defined as: “All female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.”

    Female subjects of childbearing potential and male subjects with female partners of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and four weeks after the last dose of trial medication. Adequate contraception is defined as two barrier methods, or one barrier method with a spermicide, or intrauterine device. The use of
    hormonal contraceptives should be avoided in female subjects
    of childbearing potential due to possible drug-drug
    interaction.
    E.4Principal exclusion criteria
    Bone marrow impairment as evidenced by hemoglobin < 9.0 g/dL, neutrophil count < 1.5 x 10^9/L, and/or platelets < 100 x 10^9/L.

    Renal impairment as evidenced by serum creatinine > 1.5 x ULN (upper limit of normal) and/or calculated creatinine clearance < 50 mL/min.

    Liver function and liver cell integrity abnormality as defined by total bilirubin > 1.5 x ULN, or AST/ALT > 2.5 x ULN, for subjects with liver involvement AST/ALT > 5 x ULN.

    History of central nervous system (CNS) metastases, unless subject has been previously treated for CNS metastases, is stable by CT scan without evidence of cerebral edema, and has no requirements for corticosteroids or anticonvulsants.

    History of difficulty of swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the tested product.

    Eastern Cooperative Oncology Group Performance Status (ECOG PS) greater than 1.

    Known HIV positivity, active hepatitis C, or active hepatitis B.

    Has received extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation. Prior radiation for local disease management is allowed if last fraction was completed at least 4 weeks prior to trial entry.

    Has received chemotherapy or any investigational drug in the 4 weeks prior to trial first drug administration.

    Has a history of any other significant medical disease such as major gastric or small bowel surgery, or has a psychiatric condition that might impair the subject’s well being or preclude full participation in the trial.

    Past or current history (within the last 2 years prior to inclusion) of malignancies except for the indication under this study and curatively treated: basal and squamous cell carcinoma of the skin and in-situ carcinoma of the cervix.

    Has significant cardiac conduction abnormalities and/or pacemaker.

    Is a pregnant or nursing female.

    Has retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), history of uveitis, or history of retinal vein occlusion and/or any medically relevant abnormal findings at the initial ophthalmologic examination.

    Other significant disease that in the Investigator’s opinion would exclude the subject from the trial.

    Known hypersensitivity to the trial treatment(s) or diluents (when applicable), including placebo or other comparator drug(s).

    Legal incapacity or limited legal capacity.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Run-in Part

    Dose-Limiting Toxicity (DLT) using the NCI Common Terminology Criteria for Adverse Events v3.0 (CTCAE), evaluated over the first cycle of treatment. The number and the incidence of DLTs by dose level will be used in the primary statistical analysis of the Safety Run-in part.

    Phase II Randomized Part

    Progression-Free Survival (PFS) time, defined as the time (in months) from the date of randomization to the first disease progression as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0) or death for any cause. PFS will be censored at the time of subsequent therapy before progression. The PFS Hazard Ratio (HR) of experimental arm versus control arm will be used in the primary statistical analysis of the Phase II Randomized part.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety Run-in part:
    After 1st cycle of treatment.

    Phase II Randomized Part:
    The first disease progression as reported and documented by the Investigator or death for any cause. PFS will be censored at the time of subsequent therapy before progression.
    E.5.2Secondary end point(s)
    Safety Run-in Part:
    • Treatment-emergent adverse events (TEAEs) graded according
    to the NCI-CTCAE v3.0.
    • Change in laboratory parameters and/or vital signs.
    • Plasma PK parameters (incl. Cmax, Tmax, AUC, t1/2) of SC1936369B, irinotecan and its active metabolite SN38. Concentration of 5-FU, if applicable.
    • Overall response rate: Confirmed Complete Response (CR) plus Partial Response (PR) rate (using RECIST v1.0).
    • Clinical Benefit: Confirmed CR, PR and Stable Disease (SD) rate (SD lasting at least 12 weeks) (using RECIST v1.0).
    • Exploratory candidate markers for tumor characteristics and
    predictive of anti-tumor activity.
    • Changes in levels of circulating markers in serum (e.g. cytokines).

    Phase II Randomized Part
    • Grade 3 or 4 toxicity using the NCI-CTCAE v3.0 during the treatment period, judged to be related to the trial medications.
    • TEAEs graded according to the NCI-CTCAE v3.0.
    • Change in a laboratory parameter and/or vital signs.
    • Overall response rate: Confirmed CR plus PR rate (using RECIST v1.0).
    • Clinical Benefit: Confirmed CR, PR and SD rate (SD lasting at least 12 weeks) (using RECIST v1.0).
    • Time to Progression (TTP), defined as the time (in months) from randomization date to date of progression, as reported and documented by the Investigator (i.e. radiological progression per RECIST v1.0).
    • Overall survival (OS) time, defined as the time (in months) from randomization to death due to any cause.
    • Exploratory candidate markers for tumor characteristics and predictive of anti-tumor activity.
    • Changes in levels of circulating markers in serum (e.g. cytokines).
    • Plasma PK parameters of MSC1936369B to be presented in the population PK report according to the SAP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety Run-in Part:
    On-going or at the time of analysis.

    Phase II Randomized Part:
    On-going or at the time of analysis.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    United States
    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
    Safety Run-in part: All subjects enrolled in the Safety Run-in part have completed their treatment and their end of treatment and post-treatment visits.

    Randomized Phase II part of the trial: All subjects have received the last dose of trial treatment (including 28 days of safety follow up and the EOT Visit) and two-thirds of the subjects have died (128 subjects).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 121
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 141
    F.4.2.2In the whole clinical trial 196
    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)
    After trial termination, i.e. progressive disease, the subjects have full and unrestricted access to
    appropriate diagnostic or therapeutic care at the discretion of the Investigator or another treating
    physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-25
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