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    Summary
    EudraCT Number:2014-003791-23
    Sponsor's Protocol Code Number:I4T-MC-JVDB
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-23
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2014-003791-23
    A.3Full title of the trial
    Protocol I4T-MC-JVDB
    Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second Line Gastric or Gastroesophageal Junction Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical Trial Testing the Safety of Four Ramucirumab Doses Given as Second Line Treatment to Patients with Stomach Cancer
    A.4.1Sponsor's protocol code numberI4T-MC-JVDB
    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 SponsorEli Lilly and Company
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Cyramza
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/12/1004
    D.3 Description of the IMP
    D.3.1Product nameramucirumab
    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.3.9.1CAS number 947687-13-0
    D.3.9.3Other descriptive nameRAMUCIRUMAB
    D.3.9.4EV Substance CodeSUB32795
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Second Line Gastric or Gastroesophageal Junction Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Stomach and gastroesophageal junction cancers
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10063916
    E.1.2Term Metastatic gastric 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate ramucirumab PK following various dose regimens. Assess the safety for each dose group of ramucirumab in patients with advanced gastric cancer, whose disease has progressed during or following prior combination chemotherapy
    E.2.2Secondary objectives of the trial
    Blood samples for immunogenicity testing will be collected to determine antibody production against ramucirumab.
    PFS at the first 6-week assessment, as determined by investigator assessment per RECIST 1.1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has a histopathologically or cytologically confirmed diagnosis of gastric or GEJ (Siewert Types I-III) adenocarcinoma.

    2. The patient has documented disease progression during or within 4 months after the last dose of first-line chemotherapy for metastatic disease, or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy.

    3. The patient received combination chemotherapy prior to disease progression.

    4. The patient has metastatic disease or locally advanced and unresectable disease that is measurable or nonmeasurable, but is evaluable disease by radiological imaging

    5. Patients are eligible if they are considered not appropriate, for whatever reason, for treatment with ramucirumab in combination with paclitaxel

    6. The patient has adequate organ function, including

    7. The patient is at least 18 years old (or of an acceptable age according to local regulations, whichever is older) and has provided written informed consent prior to any study-specific procedures.

    8. The patient has an estimated life expectancy of at least 12 weeks in the judgment of the investigator.

    9. The patient has resolution to maximum Grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCI 2009), of all clinically significant toxic effects of previous anticancer therapy.

    10. The patient, if male, is sterile or agrees to use a reliable method of birth control and to not donate sperm during the study and for at least 12 weeks following the last dose of study treatment. The patient, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control during the study and for 12 weeks following the last dose of study treatment.

    11. The patient, if female and of child-bearing potential, must have a negative serum or urine pregnancy test within 7 days prior to randomization.

    E.4Principal exclusion criteria
    1. The patient has squamous cell or undifferentiated gastric cancer.

    2. Within 7 days prior to randomization, the patient is receiving chronic therapy with nonsteroidal anti-inflammatory agents or with other anti-platelet agents.

    3. The patient received radiotherapy within 14 days prior to randomization.

    4. The patient received >1 line of prior therapy for the treatment of locally advanced and unresectable or metastatic gastric or GEJ adenocarcinoma.

    5. The patient received previous treatment with agents targeting the VEGF/VEGF Receptor 2 signaling pathway, including previous exposure to ramucirumab

    6. The patient has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.

    7. The patient has a significant bleeding disorder or vasculitis or had a Grade > 3 bleeding episode within 12 weeks prior to randomization.

    8. The patient experienced any arterial thromboembolic event within 6 months prior to randomization.

    9. The patient has symptomatic congestive heart failure or symptomatic or poorly controlled cardiac arrhythmia.

    10. The patient has uncontrolled hypertension.

    11. The patient underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization.

    12. The patient has a history of: gastrointestinal perforation, fistula, inflammatory bowel disease, Crohn’s disease, acute or subacute bowel obstruction or history of chronic diarrhea, cirrhosis at a level of Child-Pugh B.

    13. The patient received any previous investigational therapy within 4 half-lives of the investigational agent prior to randomization

    14. The patient has a serious illness or medical condition, or any condition (for example, psychological, geographical, or medical) that does not permit compliance with the study and follow-up procedures.

    15. The patient is pregnant or breastfeeding.

    16. The patient has a concurrent active malignancy.

    17. The patient has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture, within 28 days prior to randomization.

    18. The patient has unresected primary tumors or local recurrence following resection and is receiving anticoagulation therapy.

    19. The patient experienced any Grade 3 or 4 venous thromboembolic event (VTE) that is considered by the investigator to be life-threatening or that is symptomatic and not adequately treated by anticoagulation therapy, within 6 months prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    1. PK endpoint: Minimum ramucirumab concentration in serum.
    2. Safety endpoints evaluated will include but are not limited to the following:
    • TEAEs, AESIs, SAEs, and hospitalizations
    • Clinical laboratory tests, vital signs, and physical examinations
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis of the primary endpoints will occur after all randomized patients have completed at least 3 cycles of ramucirumab or discontinued for any reason prior to completing 3 cycles.
    E.5.2Secondary end point(s)
    1. Blood samples for immunogenicity testing will be collected to determine antibody production against ramucirumab.
    2. PFS at the first 6-week assessment, as determined by investigator assessment per RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    All Secondary and Exploratory Endpoints will be analyzed at the same time as the Primary Endpoint: after all randomized patients have completed at least 3 cycles of ramucirumab or discontinued for any reason prior to completing 3 cycles.
    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 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) 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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA25
    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
    Argentina
    Australia
    France
    Hungary
    New Zealand
    Poland
    Romania
    Russian Federation
    Slovakia
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 96
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 64
    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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 160
    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 Decision2015-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-05
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