Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-005725-29
    Sponsor's Protocol Code Number:EGF110656
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-02-01
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2007-005725-29
    A.3Full title of the trial
    A Phase III Study of ErbB2 Positive Advanced or Metastatic Gastric or Esophageal Or Gastroesophageal Junction Adenocarcinoma Treated with Capecitabine Plus Oxaliplatin with or without Lapatinib
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberEGF110656
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Tyverb
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Limited
    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 namelapatinib
    D.3.2Product code GW572016
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlapatinib
    D.3.9.1CAS number 388082-78-8
    D.3.9.2Current sponsor codeGW572016
    D.3.9.3Other descriptive namelapatinib ditosylate monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit IU/mg international unit(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects with ErbB2-positive advanced or metastatic gastric or oesophageal or gastro-oesophageal junction adenocarcinoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001150
    E.1.2Term Adenocarcinoma gastric
    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 the overall survival (OS) in subjects treated with CapeOx plus lapatinib versus CapeOx plus placebo.
    E.2.2Secondary objectives of the trial
    For both treatment arms:

    -To compare the progression free survival (PFS), response rate (RR), and duration of overall response of both treatment arms.
    -To compare the rate of clinical benefit (as defined by CR+PR+SD) of both treatment arms.
    -To compare the severity and incidence of qualitative and quantitative toxicities
    -To evaluate and compare the change in health related quality of life (HRQOL) status and symptoms.
    -To evaluate and compare the changes in unscheduled (not scheduled per protocol) medical resource utilization during treatment and follow-up phases.
    -To evaluate germline polymorphisms (DNA) of genes targeted by lapatinib plus CapeOx, and those that influence angiogenesis and may be associated with toxicity and/or clinical outcomes in patients with advanced or metastatic gastric adenocarcinoma.
    -To examine the molecular profiles of tumor tissue, serum and plasma samples to identify factors that may influence biological and clinical responses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed informed consent form

    2) Histologically confirmed gastric adenocarcinoma or adenocarcinoma of the oesophagus or gastro-oesophageal junction (for details refer to section 4.2 of protocol)

    3) Gastric or oesophageal cancer that is unresectable locally advanced

    4) Radiologically evaluable disease, according to RECIST. (scans must have been completed within 28 days prior to registration.)

    5) ErbB2 positive status assessed by local lab (IHC 3+ or FISH positive or CISH positive) from the primary or metastatic tumour.
    Tumour tissue must be supplied from all subjects at study entry and will be sent to the central laboratory for determination of centralised ErbB2 status.

    6) Age ≥18 years

    7) ECOG Performance status ≤ 2.

    8) Adequate organ function assessed within 14 days prior to randomization:

    Haematological function:
    -Absolute neutrophil count ≥ 1.5 x 10^9/L
    -Heamoglobin ≥ 9g/dL (with transfusion support if needed)
    -Platelets ≥ 100 x 10^9/L

    Hepatic function:
    -Total bilirubin ≤ 1.5 x upper limit of normal (UNL), or 2.5 x UNL in case of documented Gilberts syndrome
    -AST/ALT ≤ 3 x UNL, or 5 x UNL in case of documented liver metastases

    Renal function:
    -Serum creatinine ≤ 2.0 mg/dL and
    -Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault method)
    If serum creatinine is within institutional normal limits and calculated creatinine clearance is < 50 mL/min; a 24-hour urine creatinine clearance that is within institutional ranges of normal may be substituted

    9) Cardiac ejection fraction within institutional range of normal as measured by
    echocardiogram (ECG) or MUGA scans where an ECG cannot be performed or is inconclusive.

    10) Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube, (subjects who are nothing by mouth will be deemed eligible only after review by the study medical monitor).

    11) Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.

    12) Prior/Concurrent Therapy

    Surgery:
    -Subjects may have had prior surgery for their gastric cancer.
    -Patients must be at least 3 weeks beyond major surgery, such as gastrectomy, and must have recovered from any related toxicity.

    Chemotherapy:
    -More than 5 years since prior chemotherapy for malignancy other than gastric carcinoma
    -Prior neoadjuvant treatment that leads to resection with curative intent or prior adjuvant chemotherapy administered with curative intent is permitted. One line of treatment in this setting is allowed. First cancer recurrence must occur more than 6 months after completion of therapy when neoadjuvant or adjuvant treatment was given.

    Radiotherapy:
    -At least 4 weeks since prior radiotherapy.
    -Concurrent palliative radiotherapy for pain relief is allowed provided radiotherapy is limited to an area other than the sole site of measurable or evaluable disease

    Biologic or hormonal therapy:
    -More than 5 years since prior biological, hormonal or immuno- therapies for malignancy other than gastric carcinoma.
    E.4Principal exclusion criteria
    1) Pregnant or lactating females.

    2) Known history of active CNS disease.

    3) Uncontrolled ascites.

    4) Concurrent anti-cancer therapy (chemotherapy, radiation therapy other than for pain relief, immunotherapy, biologic therapy, hormonal therapy or surgery) while taking investigational treatment.

    5) Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma.

    6) Prior palliative chemotherapy for the treatment of gastric cancer.

    7) Prior treatment with oxaliplatin or the regimen CapeOx.

    8) Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease (such as Crohn’s disease or ulcerative colitis).

    9) Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure;
    -Myocardial infarction within past 6 months
    -New York Association Class III or IV congestive heart failure

    10) Pre-existing grade ≥ 2 motor or sensory neuropathy by CTC v3.0.

    11) Uncontrolled infection.

    12) Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject's safety.

    13) History of other malignancy except:
    -subjects who have been disease-free for 5 years
    -subjects with a history of completely resected non-melanoma skin cancer
    -subjects with successfully treated in situ carcinoma

    14) Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment.

    15. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

    16. Known history of pyruvate dehydrogenase (DPD) deficiency.

    17. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients.

    18. Use of any investigational drug within 30 days prior randomization.

    19. Use of concurrent prohibited medications that would interact with study drugs, including herbal remedies and Chinese traditional medicines for cancer, and including any medications or drugs listed in table 1 of section 5.7 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Survival (OS), which is defined as the time from randomization until death
    due to any cause, is a primary endpoint for this study.
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life and medical resource utilisation
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last subject, last visit
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 177
    F.4.2.2In the whole clinical trial 535
    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)
    Normal standard of care
    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 Decision2010-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 01:32:55 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA