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    Summary
    EudraCT Number:2011-005285-38
    Sponsor's Protocol Code Number:GM-IMAB-001-03
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-26
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2011-005285-38
    A.3Full title of the trial
    A randomized Phase II multicenter, Open Label Study Evaluating the Efficacy and Safety of IMAB362 in Combination with the EOX (Epirubicin, Oxaliplatin, Capecitabine) regimen as First-Line Treatment of Patients with CLDN18.2-positive advanced adenocarcinomas of the stomach, the esophagus or the gastroesophageal junction.(FAST)
    Рандомизирано, фаза ІІ многоцентрово, отворено изпитване за оценка на ефикасността и безопасността на IMAB362 в комбинация със схема на лечение EOX (епирубицин, оксалиплатин, капецитабин), като първа линия лечение на пациенти с положителен за антиген CLDN18.2 напреднал аденокарцином на стомаха, хранопровода или гастроезофагеалната връзка.(FAST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    advanced cancer of the stomach, the esophagus or the gastroesophageal junction
    напреднал аденокарцином на стомаха, хранопровода или гастроезофагеалната връзка
    A.3.2Name or abbreviated title of the trial where available
    FAST
    A.4.1Sponsor's protocol code numberGM-IMAB-001-03
    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 SponsorAstellas Pharma Global Development Inc.
    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 supportAstellas Pharma Global Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPSI CRO
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressBeaumont House, Langford Buisness Park, Langford Locks
    B.5.3.2Town/ cityKidlington
    B.5.3.3Post codeOX5 1GG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4418658552906309
    B.5.5Fax number+441865855295
    B.5.6E-mailbarry.crossman@psi-cro.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/803
    D.3 Description of the IMP
    D.3.1Product nameIMAB362
    D.3.2Product code IMAB362
    D.3.4Pharmaceutical form Powder for 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 INNIMAB362
    D.3.9.2Current sponsor codeIMAB362
    D.3.9.3Other descriptive namemonoclonal IgG1 antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    advanced adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
    напреднал аденокарцином на стомаха, хранопровода или гастроезофагеалната връзка
    E.1.1.1Medical condition in easily understood language
    advanced cancer of the stomach or the esophagus
    напреднал рак на стомаха или хранопровода
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001173
    E.1.2Term Adenocarcinoma of esophagus
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    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
    • Progression-free survival (PFS)
    • Safety and tolerability of IMAB362 in combination with EOX
    E.2.2Secondary objectives of the trial
    •Survival rate at 12 months
    • Overall survival (OS)
    • Time to progression (TTP)
    • Objective tumor response rate (ORR)
    • Disease control rate (DCR)
    • Duration of response (DOR)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Histologically confirmed adenocarcinoma of the stomach, the esophagus or the gastroesophageal junction
    (2) Inoperable locally advanced disease or resections with R2 outcome or recurrent or metastatic disease. After receiving treatment cycles 2 and 4 of this study protocol, patients will be reevaluated for resectability according to institutional guidelines.
    (3) CLDN18.2 expression confirmed by immunohistochemistry on paraffin embedded tumor tissue sample. Tumors with a staining intensity of 2+ or 3+(the sum is decisive) in at least 40 % of the tumor cells.
    (4) Measurable and/or non-measurable disease as defined according to RECISTv1.1.
    (5) Age ≥ 18 years.
    (6) Written Informed Consent Form.
    (7) ECOG performance status (PS) 0-1.
    (8) Life expectancy > 3 months.
    (9) HER2/neu negative patients and patients with HER2/neu positive status but not eligible to trastuzumab therapy in discretion of the investigator.
    (10) Adequate cardiac function. Formal measurement of left cardiac ejection fraction is ≥ 55%.
    (11) Adequate hepatic function; bilirubin < 1.5 x ULN, AST and ALT < 2.5 x ULN (5 x ULN if liver metastases are present).
    (12) Adequate renal function; creatinine < 1.5 x ULN, glomerular filtration rate (GFR) ≥51ml/minute calculated or measured. If the calculated GFR is <51 ml/min then a measured GFR based on 24 hours urine is required. The measured GFR should always take precedence over the calculated GFR.
    (13) Adequate hematological function; absolute neutrophil count (ANC) ≥1.5x10e9/l; white blood cell (WBC) count 3.5 ≥ x10e9/l; platelets ≥ 100x10e9/l; hemoglobin (Hb) ≥ 9 g/dl (can be post-transfusion).
    (14) Women of childbearing potential (last menstruation less than 2 years prior to enrollment): Negative blood serum pregnancy test (β-HCG) at screening phase and using a highly effective method of contraception during the treatment phase and for 4 months after the last infusion of the study drug.
    (15) Male patients whose sexual partners are women of childbearing potential must use condoms during the treatment phase and for 6 months after the last infusion of the study drug.
    (16) The partners of the patients must also apply contraceptive methods.
    E.4Principal exclusion criteria
    (1) Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanized or chimeric antibodies.
    (2) Prior severe allergic reaction or intolerance to the chemotherapeutics used in this study or any excipient in the respective formulations.
    (3) Previous chemotherapy for advanced disease.
    (4) Previous perioperative chemotherapy with curative intention within 6 months of start of study treatment. If interval is longer than 6 months(counted from the stop date of the perioperative chemotherapy), patients are allowed.
    (5) Radiotherapy within 4 weeks of start of study treatment (cycle 1, day1; 2 week interval allowed if palliative RTx given to bone metastatic side peripherally and patient recovered from acute toxicity).
    (6) Other investigational agents or devices concurrently or within 4 weeks prior to this study (cycle 1, day 1).
    (7) Known HIV infection or known symptomatic hepatitis (A, B, C).
    (8) Symptomatic cerebral metastases.
    (9) Clinically significant (i.e. active) cardiac disease. History of myocardial infarction or hospitalization for congestive heart failure within 12 months of enrollment.
    (10) Other clinically significant disease or co-morbidity which may adversely affect the safe delivery of treatment within this trial including, but not limited to any of the following: ongoing or active infection requiring parenteral antibiotics, uncontrolled hypertension, present cardiac arrhythmia with serious haemodynamic consequences or unstable angina pectoris.
    (11) Psychiatric illness or social situations that would preclude study compliance.
    (12) Pregnancy or breastfeeding.
    (13) Gastric bleeding within last 2 weeks, only symptomatic peptic ulcer.
    (14) Concurrent systemic immunosuppressive therapy, in particular systemic corticoids should be stopped 2 weeks prior to therapy (Cycle 1, Day 1). Inhaled and topically applied steroids are the exception and allowed. Systemic steroids should be avoided as long as patient is under study medication. Exception is otherwise uncontrollable nausea/vomiting.
    (15) Previous treatments with maximum cumulative doses of epirubicin >500 mg/m² and/or other anthracyclines and anthracenediones.
    (16) Treatment with Sorivudine or analogs.
    (17) Known peripheral neuropathy > Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible).
    (18) Malabsorption syndrome or inability to take oral medication (administration of capecitabine by naso-gastric or jejunostomy feeding tube is permitted).
    (19) Known dihydropyrimidine dehydrogenase (DPD) deficiency.
    (20) History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan if clinically relevant.
    (21) Patients should have no evidence of dyspnea at rest.
    (22) Prior or current active autoimmune disease (like inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis or other rheumatologic disease) requiring management with immunosuppression. Asthma and chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable.
    (23) Sinusoidal obstruction syndrome, formerly known as veno-occlusive disease (VOD), if present, should be stable or improving.
    E.5 End points
    E.5.1Primary end point(s)
    PFS is defined as the time from randomization to the first observation of disease progression or death from any cause. Patients without documented progression or death will be censored as of the last tumor evaluation determining lack of progression.

    Safety and tolerability of IMAB362 in combination with EOX.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Imaging will be performed to determine tumor burden at the following timepoints:
    • Baseline: ≤9 - 1 days prior to initiation of therapy (baseline) if the last assessment is older than 4 weeks
    • 6-weekly intervals until week 31, meaning week 7, 13, 19, 25, 31 (day 1 ± 4 days of these weeks)
    • every 9 weeks thereafter, meaning week 40, 49, ff (day 1± 4 days of these weeks)
    • anytime in between if there is clinical indication for progression
    E.5.2Secondary end point(s)
    • Time to Progression is defined as the time from randomization of therapy to the first observation of confirmed disease progression. For patients who have not progressed either clinically or on the last scan, they will be censured as of the last tumor evaluation.
    • To determine survival status at 12 months following initiation of therapy each patient will be classified as alive or dead (irrespective of cause of death). For this purpose, upon completion of the last cycle, all patients will continue to be followed until death or loss to follow up. Patients who discontinue treatment due to progression will be followed in the same manner.
    • Overall survival is defined as the time from randomization to death from any cause or last contact if alive.
    • Objective Response Rate comprises the fraction of patients with CR, PR according to RECIST v1.1. It is set in relation to the ITT population and PP population.
    • Disease Control Rate is defined as the fraction of patients with CR or PR or SD according to RECIST v1.1. It is set in relation to the ITT population and PP population.
    • Duration of response is determined as the time when criteria for CR, PR, SD are first met until the first date that recurrent or progressive disease or death occur.
    • Longitudinal changes in serum tumor marker levels i.e. CEA, CA19.9, CA125 and CA15.3 will be determined to obtain additional data on tumor load. If tumor markers are initially above normal limit, they must normalize for a patient to be considered in complete response.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints for all imaging assessments and tumor marker level evaluation to determine CR, PR, SD or PD are:
    • Imaging will be performed to determine tumor burden at the following timepoints:
    • Baseline: ≤9 - 1 days prior to initiation of therapy (baseline) if the last assessment is older than 4 weeks
    • 6-weekly intervals until week 31, meaning week 7, 13, 19, 25, 31 (day 1 ± 4 days of these weeks)
    • every 9 weeks thereafter, meaning week 40, 49, ff (day 1± 4 days of these weeks)
    • anytime in between if there is clinical indication for progression
    Follow-up at 12 months for overall survival
    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 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 Yes
    E.6.13.1Other scope of the trial description
    - Immunogenicity assessement
    - to explore in advance the effect size and adverse event profile of IMAB362 in combination with chemotherapy
    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 trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Bulgaria
    Czech Republic
    Germany
    Latvia
    Russian Federation
    Ukraine
    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 years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 116
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 231
    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 the end of the participation in the trial, the patients will receive treatment at their investigator’s discretion according to current local medical practice without the sponsor’s involvement.
    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 Decision2012-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-01-31
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