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    Summary
    EudraCT Number:2017-000329-11
    Sponsor's Protocol Code Number:Elderly
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-12-22
    Trial 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 ConcernedGermany - PEI
    A.2EudraCT number2017-000329-11
    A.3Full title of the trial
    Aflibercept and 5-FU vs. FOLFOX as 1st line treatment for elderly or frail elderly patients with metastatic colorectal cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of a standard chemotherapy (FOLFOX) with a combination of Aflibercept and 5FU for elderly or frail elderly patients with metastatic colorectal cancer
    A.3.2Name or abbreviated title of the trial where available
    Elderly / AIO KRK 0117
    A.4.1Sponsor's protocol code numberElderly
    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 SponsorIKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIKF Klinische Krebsforschung GmbH at Krankenhaus Nordwest
    B.5.2Functional name of contact pointIKF
    B.5.3 Address:
    B.5.3.1Street AddressSteinbacher Hohl 2-26
    B.5.3.2Town/ cityFrankfurt
    B.5.3.3Post code60488
    B.5.3.4CountryGermany
    B.5.4Telephone number00496976014420
    B.5.5Fax number00496976013655
    B.5.6E-mailinfo.ikf@khnw.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 Yes
    D.2.1.1.1Trade name Zaltrap
    D.2.1.1.2Name of the Marketing Authorisation holdersanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAflibercept
    D.3.4Pharmaceutical form Concentrate for 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.3.8INN - Proposed INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    metastatic colorectal cancer
    E.1.1.1Medical condition in easily understood language
    metastatic 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 21.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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
    To assess the rates of progression-free survival at six months calculated from the start of treatment in elderly / frail elderly patients with metastatic colorectal cancer undergoing a 1st line treatment.
    E.2.2Secondary objectives of the trial
    To compare the treatment arms with respect to:
    Safety
    - Dose intensities of study medication
    - Type, incidence and severity of AEs and SAEs
    - Laboratory parameters

    Efficacy
    - Response rate assessed by the local investigators
    - Overall and progression-free survival

    Patient reported outcomes
    - Quality of life
    - Geriatric assessment
    - Overall treatment utility

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. To enter this trial the oncologist has to confirm, that the patient was in his or her opinion not a candidate for standard full-dose combination therapy. Moreover, the oncologist has to state the reason for entering the trial (Advanced age alone versus both age and frailty). As an operational definition for frailty the G8 screening tool will be used upon inclusion of the patient in a standardized manner. Briefly, G8 is an established screening tool that includes seven items from the Mini Nutritional Assessment (MNA) and an age-related item (<80, 80 to 85, or 85 years). The total score can range from 0 to 17. The result on the G8 is considered abnormal if the score is ≤14, indicating a geriatric risk profile.
    2. Patients have to have histologically confirmed mCRC with unidimensionally measurable inoperable advanced or metastatic disease
    3. ECOG performance status of 2 or better.
    4. Life expectancy of 3 months or longer at enrolment
    5. Patients >70 years with no upper age limit
    6. Previous adjuvant chemotherapy is allowed if completed more than 6 months before randomisation
    7. Previous rectal (chemo)radiotherapy is allowed if completed more than 6 months before randomisation
    8. Hematological status:
    • Neutrophils (ANC) ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin ≥ 9 g/dL
    9. Adequate renal function:
    • Serum creatinine level ≤ 1.5 x upper limit normal (ULN)
    10. Adequate liver function:
    • Serum bilirubin ≤ 1.5 x upper limit normal (ULN)
    • Alkaline phosphatase ≤ 2.5 x ULN (unless liver metastases are present, then < 5 x ULN in that case)
    • AST and ALT < 3 x ULN (unless liver metastases are present then < 5 x ULN in that case)
    11. Proteinuria < 2+ (dipstick urinalysis) or ≤ 1 g/24hour
    12. Signed and dated informed consent, and willing and able to comply with protocol requirements
    13. Regular follow-up feasible
    14. Male patients with a partner of childbearing potential must agree to use effective contraception (Pearl Index < 1) during the course of the trial and at least 3 months after last administration of the study drug.
    E.4Principal exclusion criteria
    1. Prior systemic chemotherapy for mCRC
    2. Other concomitant or previous malignancy, except:
    • Adequately treated in-situ carcinoma of the uterine cervix
    • Basal or squamous cell carcinoma of the skin
    • Cancer in complete remission for > 5 years
    3. Any other serious and uncontrolled non-malignant disease, major surgery or traumatic injury within the last 28 Days
    4. History or evidence upon physical examination of CNS metastasis unless adequately treated (irradiation and no seizure with appropriate treatment)
    5. Uncontrolled hypercalcemia
    6. Pre-existing peripheral neuropathy (NCI grade ≥2)
    7. Concomitant protocol unplanned antitumor therapy (e.g. chemotherapy, molecular targeted therapy, immunotherapy),
    8. Treatment with any other investigational medicinal product within 28 days prior to study entry.
    9. Significant cardiovascular disease:
    • Cardiovascular accident or myocardial infarction or unstable angina ≤6 months before start of study treatment
    • Severe cardiac arrhythmia
    • New York Heart Association grade ≥2 congestive heart failure
    • Uncontrolled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy.
    • History of stroke or transient ischemic attack ≤6 months before start of study treatment
    • Coronary/peripheral artery bypass graft ≤6 months before start of study treatment.
    • Deep vein thrombosis or thromboembolic events ≤1 month before start of study treatment
    10. Patients with known allergy to any excipient to study drugs,
    11. Any of the following within 3 months prior to randomization: Grade 3-4 gastrointestinal bleeding/hemorrhage, treatment resistant peptic ulcer disease, erosive oesophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism or other uncontrolled thromboembolic event.
    12. Bowel obstruction.
    13. Treatment with CYP3A4 inducers unless discontinued > 7 days prior to randomization
    14. Known dihydropyrimidine dehydrogenase (DPD) deficiency
    15. Involvement in the planning and/or conduct of the study (applies to both Sanofi staff and/or staff of sponsor and study site)
    16. Patient who might be dependent on the sponsor, site or the investigator
    17. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.
    18. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients free of progression at the time point of 6 months calculated from the start of treatment. Response assessment will be done in a standardized manner using CT scan.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 6 months calculated from the start of treatment.
    E.5.2Secondary end point(s)
    Safety
    • Dose intensities of study medication
    • Type, incidence and severity of AEs, SAEs (CTCAE version 4.03)
    • Dose reduction or discontinuation of study drug due to adverse events
    • Rate of treatment discontination due to toxicity
    • Type, incidence and severity of laboratory abnormalities

    Efficacy
    • Response rates (response will be assessed by the local investigator using RECIST criteria v. 1.1; CT scans are conducted at 2, 4 and 6 months and every two months thereafter)
    • Overall and progression-free survival (OS)

    Patient reported outcomes
    • Quality of life using EQ5D
    • Geriatric assessment using G8, ADL and IADL
    • Overall treatment utility (as defined in FOCUS2 trial)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Safety and tolerability: continuously
    - Response Rate (ORR): at 2, 4 and 6 months and every two months thereafter
    - Overall survival (OS) and Progression-free Survival (PFS): continuously
    - Patient reported outcomes: QoL baseline and every 4 weeks; geriatric assessment: baseline, after 3 and 6 months; OTU: after 3 and 6 months






    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 concerned35
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    Database closure is defined as the end of the trial: Sites need to collect survival data of patients and are involved in the data cleaning process actively (e.g. additional source data may be requested and additonal monitoring visits may be neccessary). Therefore, database closure is considered the end of the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 196
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state196
    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)
    None
    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 Decision2018-04-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-02
    P. End of Trial
    P.End of Trial StatusOngoing
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