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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-007798-18
    Sponsor's Protocol Code Number:AIO/CAO-STO-0801
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2008-007798-18
    A.3Full title of the trial
    An Open Label Randomized Controlled Phase II Trial of Panitumumab in Combination with Epirubicin, Cisplatin and Capecitabine (ECX) versus ECX Chemotherapy alone in Subjects with Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ECX + Panitumumab vs. ECX alone in subjects with locally advanced gastric cancer or cancer of the gastroesophageal junction
    A.3.2Name or abbreviated title of the trial where available
    NEOPECX
    A.4.1Sponsor's protocol code numberAIO/CAO-STO-0801
    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 SponsorAIO-Studien-gGmbH
    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 supportAmgen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWiSP Wissenschaftlicher Service Pharma GmbH
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressKarl-Benz-Str. 1
    B.5.3.2Town/ cityLangenfeld
    B.5.3.3Post code40764
    B.5.3.4CountryGermany
    B.5.4Telephone number+4902173853130
    B.5.5Fax number+49021738531311
    B.5.6E-mailinfo@wisp.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 Vectibix
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    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 namePanitumumab
    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 INNPANITUMUMAB
    D.3.9.1CAS number 339177-26-3
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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
    Subjects with Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction
    E.1.1.1Medical condition in easily understood language
    Subjects with Locally Advanced Gastric Cancer or Cancer of the Gastroesophageal Junction
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10017758
    E.1.2Term Gastric cancer
    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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal 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 compare prevalence of pT3/T4 categories (in reference to UICC 2002 criteria, Appendix F) between subjects receiving panitumumab plus epirubicin, cisplatin and capecitabine (ECX) versus subjects treated with ECX chemotherapy alone.
    E.2.2Secondary objectives of the trial
    To compare prevalence of pN2/N3 categories between subjects receiving panitumumab plus epirubicin, cisplatin and capecitabine (ECX) versus subjects treated with ECX chemotherapy alone.
    To assess if the addition of panitumumab to ECX chemotherapy increases the histological complete and subtotal (< 10% residual tumour) response rates, R0 resection rate, progression-free survival time, time to relapse following surgery, time to treatment failure and overall survival in subjects with locally advanced gastric cancer or cancer of the gastroesophageal junction. To assess the overall safety and efficacy of ECX with or without panitumumab in this study population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Competent to comprehend, sign, and date an IEC-approved informed consent form, written informed consent.
    - Of either gender and aged 18 years or more.
    - Diagnosed with histologically confirmed adenocarcinoma of the stomach or the gastroesophageal junction of Type I/II/III according to the classification of Siewert et al, 1996 (see Appendix E).
    - Stage uT/3 or 4 N0/+ and M0 (see Appendix F) disease evaluated by endoscopic ultrasound, spiral computed tomography of the chest, abdomen and pelvis and by laparoscopy in uT3/T4 tumors.
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    - Haematologic function, as follows (within 7 days of randomisation):
    - Leucocyte count ≥ 4,000/mm3
    - Platelet count ≥100,000/mm3.
    - Haemoglobin ≥10 g/dl
    - Renal function, as follows (within seven days of randomisation):
    - Serum creatinine ≤ 1.5x of upper limit of normal (ULN)
    - Creatinine clearance > 60 ml/kg/min measured either by 24-h urine sampling or calculated by using the Cockgroft-Gault formula .
    - Hepatic function, as follows (within seven days of randomisation):
    - Aspartate aminotransferase (AST) ≤3 x ULN
    - Alanine aminotransferase (ALT) ≤3 x ULN.
    - Bilirubin ≤ 1.5 x ULN.
    - Metabolic function, as follows (within 7 days of randomisation):
    - Magnesium ≥ lower limit of normal.
    - Calcium ≥ lower limit of normal.
    - Subject is deemed a good candidate for surgery.
    E.4Principal exclusion criteria
    - Any metastatic disease.
    - Other malignant tumours less than five years old. Exceptions include basocellular carcinoma, in situ cancer of the cervix of the uterus, or any curatively-treated other malignancies without evidence of disease for more than five years.
    - Malignant ascites or pleural effusion.
    - Prior anti-EGFr antibody therapy (e.g. cetuximab) or treatment with small molecule EGFr tyrosine kinase inhibitors (e.g. erlotinib).
    - Prior chemotherapy, radiotherapy or antibody therapy for gastric cancer or cancer of the gastro-oesophageal junction.
    - Concomitant therapy with sorivudine or analogue compounds.
    - Known previous or ongoing abuse of narcotic drug, other medication or alcohol.
    - Significant cardiovascular disease including New York Heart Association (NYHA) grade II or greater congestive heart failure, peripheral arterial occlusive disease stage II or greater, symptomatic coronary heart disease, insufficiently treated arterial hypertension, unstable angina or myocardial infarction within 12 months before initiating study treatment or a history of ventricular arrhythmia.
    - History or evidence upon physical examination of CNS disease unless adequately treated, seizure not controlled with standard medical therapy, or history of stroke.
    - History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan.
    - Pre-existing polyneuropathy grade >1 according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI CTCAE), except for loss of tendon reflex as the only symptom.
    - Treatment for systemic infection within 14 days before initiating study treatment.
    - Active inflammatory bowel disease, serious gastric ulceration or other bowel disease causing chronic diarrhoea (defined as > 4 loose stools per day).
    - Suspected or known dihydropyrimidine dehydrogenase deficiency (DPD).
    - Thrombosis or severe bleeding within six months prior to entry into the study (except for bleeding of the tumour before its surgical resection), evidence of bleeding diathesis or coagulopathy, or current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants for therapeutic purposes.
    - History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results.
    - Known positive test for human immunodeficiency virus infection, hepatitis C virus or chronic active hepatitis B infection.
    - Known allergy to the investigational product, to any of its excipients, to monoclonal antibodies, or to any of the components of the chemotherapy regimen.
    - Any co-morbid disease that would increase risk of toxicity.
    - Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures.
    - Any investigational agent or participation in another clinical trial within 30 days prior to randomisation.
    - Must not have had a major surgical procedure within 28 days of randomisation.
    - Subject who is pregnant or breast feeding.
    - Woman or man of childbearing potential not consenting to use adequate contraceptive precautions (intrauterine contraceptive device, contraceptive implants, injectables (hormonal depot), transdermal hormonal contraception (contraceptive patch), sexual abstinence or vasectomised partner) during the course of the study and for six months after the last study drug administration for women and men. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-child-bearing potential.
    - Subject unwilling or unable to comply with study requirements.
    - Hearing impairment
    E.5 End points
    E.5.1Primary end point(s)
    Frequencies of pT3/T4 categories (in reference to the UICC 7th Edition-2010 criteria) after surgery. Subjects prematurely discontinuing without a post-surgical tumour response assessment will be considered as non responders.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery
    E.5.2Secondary end point(s)
    Frequencies of pN2/N3 categories after surgery
    Histological complete and subtotal response
    R0 resection rate
    Perioperative complication rate
    Postoperative mortality
    Progression free survival
    Time to relapse following surgery
    Time to treatment failure
    Overall survival time
    Toxicity/safety
    Translational research
    E.5.2.1Timepoint(s) of evaluation of this end point
    Frequencies of pN2/N3 categories after surgery -> after surgery
    Histological complete and subtotal response -> after surgery
    R0 resection rate -> after surgery
    Perioperative complication rate -> after surgery
    Postoperative mortality -> on event
    Progression free survival -> on event
    Time to relapse following surgery -> on event
    Time to treatment failure -> on event
    Overall survival time -> on event
    Toxicity/safety -> continuously
    Translational research -> after surgery
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard chemotherapy with Epirubicin Cisplatin Capecitabine (ECX)
    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 concerned25
    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 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
    provided in the protocol
    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 months0
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 state170
    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 treatment in the study the subjects are treated according to the knowledge then available. Panitumumab will not be provided to subjects outside the study or after the end of treatment in the study.
    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 Decision2010-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-01
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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