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    Summary
    EudraCT Number:2009-012040-16
    Sponsor's Protocol Code Number:EMR 62242–004
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-08-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-012040-16
    A.3Full title of the trial
    An open-label, randomized, controlled, multi-center, Phase I/II trial investigating 2 EMD 525797 doses in combination with cetuximab + irinotecan versus cetuximab + irinotecan alone, as second-line treatment for subjects with k-ras wild type (WT) metastatic colorectal cancer (mCRC). Subjects with k-ras WT mCRC will be eligible for enrollment if they are refractory to or progressive after first-line chemotherapy
    with an oxaliplatin-containing therapeutic regimen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EMD 525797 in combination with Cetuximab and Irinotecan in k-ras Wildtype Metastatic Colorectal Cancer
    A.4.1Sponsor's protocol code numberEMR 62242–004
    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 KGaA
    B.1.3.4CountryGermany
    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 KGaA, Darmstadt
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Straße 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    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 nameDI-17E6
    D.3.2Product code EMD 525797
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeEMD525797
    D.3.9.3Other descriptive nameDI-17E6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typehumanized antibody (deimmunized IgG2)
    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
    Subjects with k-ras WT, metastatic colorectal cancer who have failed a fist line chemotherapy with an oxaliplatin-containing regimen will be eligible for this trial.
    E.1.1.1Medical condition in easily understood language
    Colorectal cancer
    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 LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal 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
    The primary objectives are:
    • To characterize the safety and tolerability profile of repeated administration of different EMD 525797 dose levels in combination with cetuximab and irinotecan in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen (Safety Part);
    • To assess the anti-cancer activity of 2 EMD 525797 doses in terms progression-free
    survival time in subjects with k-ras WT mCRC after failure of first-line therapy with an
    oxaliplatin-containing regimen (Randomized Part).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    • Further evaluate the efficacy of 2 EMD 525797 doses with respect to Overall survival (OS) time, Time to tumor progression (TTP), tumor response
    (RECIST criteria [Version 1.0]), and Time to treatment failure (TTF);
    • Evaluate the pharmacokinetic (PK) profile of EMD 525797 and its effects on cetuximab as well as the PK profile of cetuximab and its effect on EMD 525797.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Signed and dated written informed consent prior to any specific trial procedure and the ability to comply with the trial and follow-up procedures;
    • Age ≥18 years of male or female gender;
    • Subjects with histologically-confirmed k-ras WT CRC with documented distant metastasis;
    • Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease;
    • Failed an oxaliplatin regimen for metastatic disease. Failure is defined as either PD (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen, or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing
    retreatment;
    • At least 1 radiographically documented measurable lesion in a previously non-irradiated area according to RECIST (Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as
    ≥2 cm by conventional techniques or ≥1 cm by spiral CT scan;
    • ECOG performance status 0-1, or KPS ≥80%;
    • Acceptable laboratory parameters including ANC
    ≥1.5 x 10E9/L, platelets ≥100 x 109/L, hemoglobin ≥9 g/dL (without transfusions), bilirubin ≤1.5 x ULN, ASAT ≤5 x ULN, ALAT ≤5 x ULN, serum creatinine ≤1.25 x ULN and/or creatinine clearance ≥50 ml/min, PT, INR, and PTT within normal limits and sodium and potassium within normal limits or ≤10% above or below
    (supplementation permitted);
    • Effective contraception for both male and female subjects if the risk of conception exists.
    E.4Principal exclusion criteria
    • Treatment in another clinical trial within the past 30 days or previous treatment with any inhibitor of EGFR;
    • Known brain metastasis and/or leptomeningeal disease;
    • Radiotherapy (except localized radiotherapy for pain relief), major surgery, or any investigational drug in the 30 days before the start of trial treatment entry, planned major surgery during the trial;
    • Concurrent chronic systemic immune or hormone therapy not indicated in this trial protocol (except for physiologic replacement; steroids up to 10 mg of prednisone equivalent or topical and inhaled steroids are allowed);
    • Clinically relevant coronary artery disease (New York Heart Association [NYHA] functional angina classification III/IV), congestive heart failure (NYHA III/IV), or clinically relevant cardiomyopathy;
    • Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg under resting conditions;
    • History of myocardial infarction in the last 12 months, or a high risk of uncontrolled
    arrhythmia, coagulation disorder associated with bleeding or recurrent thrombotic events, recent peptic ulcer disease (endoscopically proven) within 6 months of trial treatment start, chronic inflammatory bowel disease, or acute/chronic ileus;
    • Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection;
    • Presence of any contra-indications or known hypersensitivity to treatment with EMD 525797, cetuximab, and irinotecan, or to any of the excipients of these drugs;
    • Pregnancy or lactation period;
    • Concurrent treatment with a non-permitted drug;
    • Previous malignancy other than CRC in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix;
    • Medical or psychological conditions that would not permit the subject to complete the trial or sign informed consent;
    • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who are suffering or have suffered from such;
    • Legal incapacity or limited legal capacity;
    • Significant disease which, in the Investigator’s opinion, would exclude the subject from the trial.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Part:
    • To characterize the safety and tolerability profile of repeated administration of different EMD 525797 dose levels in combination with cetuximab and irinotecan in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen.
    Randomized Part:
    • To assess the anti-cancer activity of 2 EMD 525797 doses in terms of progression-free survival time in subjects with k-ras WT mCRC after failure of first-line therapy with an oxaliplatin-containing regimen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 173 events have been observed
    E.5.2Secondary end point(s)
    The secondary endpoints of the trial are OS time, TTP, TTF, Tumor Response, Disease Control, safety, and tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 173 events have been observed
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    to characterize the safety and tolerability profile
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    there is no real comparator as it is a add on design
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA47
    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
    Belgium
    Bulgaria
    Czech Republic
    Germany
    Greece
    Hungary
    Israel
    Poland
    Russian Federation
    Spain
    United Kingdom
    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
    An updated efficacy evaluation will be provided after 173 subjects experienced death or disease progression.
    The trial will end when both conditions will apply:
    • all subjects have received the last dose of trial treatment (including 28 days of
    safety follow-up and the EOT Visit)
    • 2/3 of the subjects have experienced death
    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 months2
    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 months2
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    May include women of childbearing pot. w/ contraception,however this is not the complete patient pop
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 209
    F.4.2.2In the whole clinical trial 237
    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 a subject has completed the trial or has withdrawn early, usual treatment will be administered, if required, in accordance with the trial site’s standard of care and generally accepted medical practice and depending on the subject’s individual medical needs.
    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 Decision2011-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-23
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