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    Summary
    EudraCT Number:2008-005964-15
    Sponsor's Protocol Code Number:IMCLCP12-0715
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-28
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2008-005964-15
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blinded Study of IMC-1121B and
    Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment
    of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
    Following Disease Progression on First-Line Platinum- or
    Fluoropyrimidine-Containing Combination Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating new drug, IMC-1121B, in patients with advanced cancer of the stomach/oesophagus that has grown despite standard chemotherapy (combination of chemotherapy including platinum or fluoropyrimidine). Study has two arms. Patients will be assigned "randomly" to either arm: Arm1: 2/3 of patients receive IMC-1121B and best supportive care; Arm2: 1/3 receive an inactive substance (placebo) and best supportive care. Neither the patient nor the doctor will know the treatment arm.
    A.4.1Sponsor's protocol code numberIMCLCP12-0715
    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 SponsorImClone LLC
    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 supportImClone Systems Corporation, a wholly-owned subsidiary of Eli 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 organisationImClone Systems International GmbH
    B.5.2Functional name of contact pointClinical Trials Info
    B.5.3 Address:
    B.5.3.1Street AddressAm Taubenfeld 21/ 2
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69123
    B.5.3.4CountryGermany
    B.5.4Telephone number+49622170509888
    B.5.5Fax number+49622170509889
    B.5.6E-mailClinicalTrials@imclone.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 nameramucirumab
    D.3.2Product code IMC-1121B
    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.3.8INN - Proposed INNRamucirumab
    D.3.9.1CAS number 947 687-13-0
    D.3.9.2Current sponsor codeIMC-1121B
    D.3.9.3Other descriptive namerecombinant human IgG1 monoclonal antibody (MAb)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Gastric Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of stomach/oesophagus with spreading of disease to other parts of the body
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the overall survival (OS) of patients with metastatic gastric cancer (including adenocarcinomas of the gastroesophageal junction [GEJ]) following disease progression on first-line platinum- or fluoropyrimidine-containing combination chemotherapy who undergo treatment with the MAb IMC-1121B plus BSC versus placebo plus BSC.
    E.2.2Secondary objectives of the trial
    - To evaluate the progression-free survival (PFS), including 12-week PFS rate,
    associated with IMC-1121B versus placebo
    - To evaluate the objective response rate (ORR)
    - To evaluate the duration of response
    - To evaluate the quality of life (QoL)
    - To evaluate the safety profile of IMC-1121B
    - To examine the pharmacodynamic profile of IMC-1121B
    - To assess the immunogenicity of IMC-1121B
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Each patient must meet the following criteria to be enrolled in this study.
    1. Histologically- or cytologically-confirmed gastric carcinoma, including gastric adenocarcinoma or GEJ adenocarcinoma.
    2. Metastatic disease or locally recurrent, unresectable disease with measurable lymph node metastases.
    3. Measurable disease and/or evaluable disease. Measurable disease is defined as at least one unidimensionally-measurable target lesion (≥ 2 cm with conventional techniques or ≥ 1 cm by spiral CT), as defined by RECIST. Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST.
    4. Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy.
    5. Disease is not amenable to potentially curative resection.
    6. Patient is ≥ 18 years of age.
    7. Patient has a life expectancy of ≥ 12 weeks.
    8. Patient resolution to Grade ≤ 1 (or to Grade ≤ 2 in the case of neuropathy) by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3.0, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (with the exception of alopecia).
    9. ECOG PS score of 0-1.
    10. The patient has adequate hepatic function as defined by a total bilirubin ≤ 1.5 mg/dL (25.65 µmol/L), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x the upper limit of normal (ULN) [or 5.0 x the ULN in the setting of liver metastases].
    11. The patient has adequate renal function as defined by a serum creatinine ≤ 1.5 x the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥ 40 mL/minute (ie, if serum creatinine is > 1.5 x the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed).
    12. The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis ([UA]; if urine dipstick or routine analysis is ≥ 2+, a 24-hour urine collection for protein must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study).
    13. The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL.
    14. The patient must have adequate coagulation function as defined by International Normalized Ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN (unless receiving anticoagulation therapy). Patients on anticoagulation therapy with unresected primary tumors or local tumor recurrence following resection are not eligible.
    15. If the patient has received prior anthracycline therapy as part of his or her first-line regimen, the patient is able to engage in ordinary physical activity without significant fatigue or dyspnea.
    16. Because the teratogenicity of IMC-1121B is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods).
    17. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization.
    18. Able to provide informed written consent and is amenable to compliance with protocol schedules and testing.
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study.
    1. Documented and/or symptomatic brain or leptomeningeal metastases.
    2. Experienced any Grade 3-4 gastrointestinal bleeding within 3 months prior to randomization.
    3. Experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to randomization.
    4. Ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator.
    5. Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements.
    6. Uncontrolled or poorly-controlled hypertension despite standard medical management.
    7. Patient has a serious or nonhealing wound, ulcer, or bone fracture.
    8. Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer within 2 weeks prior to randomization.
    9. Received any investigational therapy within 30 days prior to randomization.
    10. Undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization.
    11. Received prior therapy with an agent that directly inhibits VEGF or VEGFR-2 activity (including bevacizumab), or any antiangiogenic agent.
    12. Receiving chronic antiplatelet therapy, including aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen, naproxen, and others), dipyridamole or clopidogrel, or similar agents. Once-daily aspirin use (maximum dose 325 mg/day) is permitted.
    13. Patient has elective or planned major surgery to be performed during the course of the clinical trial.
    14. Patient has a known allergy to any of the treatment components.
    15. Pregnant or lactating.
    16. Known to be positive for infection with the human immunodeficiency virus.
    17. Known alcohol or drug dependency.
    18. Patient has a concurrent active malignancy other than adequately-treated nonmelanomatous skin cancer, other noninvasive carcinoma, or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that he/she has been free of disease for > 3 years.
    E.5 End points
    E.5.1Primary end point(s)
    (1) Overall Survival (OS):

    Overall survival is defined as the time from the date of randomization to the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    (1) Date of death from any cause captured per patient
    E.5.2Secondary end point(s)
    (1) Proportion of Participants Who are Progression-free (PFS) at Week 12:
    The 12-week progression-free survival (PFS) rate is defined as the proportion of participants that are alive and progression-free 12 weeks after randomization.

    (2) Proportion of Participants with Objective Response (Objective Response Rate):
    The objective response rate (ORR) is equal to the proportion of participants achieving a best overall response of partial or complete response (PR + CR).

    (3) Duration of Response: Duration of response is the interval from date of initial documented response (complete response or partial response) to the first documented date of disease progression or death.

    (4) Change from Baseline in Quality of Life (QoL) as measured by the European Organisation for Research and Treatment of Cancer (EORTC-QLQ-C30) Survey.

    (5) Number of Participants with Adverse Events.

    (6) Pharmacodynamics (PD): Maximum concentration (Cmax) of IMC-1121B

    (7) Change from Baseline in Antibodies against IMC-1121B.

    (8) Progression-free Survival (PFS). Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever is first.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation after randomization captured by patient:

    (1)-(3), (8): PFS, ORR, DOR, Imaging (CT/MRI)/tumor assessment: baseline, every 6 weeks, end of therapy

    (4) EORTC-QLQ-C30: baseline, every 6 weeks

    (5) AE: baseline, every two weeks, end of therapy, 30-day follow-up

    (6) PD: baseline, week 4, week 8, end of therapy, 30-day follow-up

    (7) Immunogenicity: baseline, every 6 weeks, 30-day follow-up
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    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 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    European Union
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Egypt
    India
    Indonesia
    Jordan
    Korea, Republic of
    Lebanon
    Malaysia
    Mexico
    New Zealand
    Philippines
    Russian Federation
    Taiwan
    Thailand
    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
    The end of trial is defined as the date when:
    - Sufficient events have been observed for final analysis of the primary endpoint; and
    - The last patient has discontinued study treatment and completed the 30-day safety follow-up visie (or all advarse events considered at least possibly-related to IMC-1121B or placebo have resolved, stabilized, returned to baseline, or been deemed irreversible).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1Number of subjects for this age range: 0
    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: 165
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 348
    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)
    Treatment or care after subject has ended participation in the trial as described in the protocol.
    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 Decision2010-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-17
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