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    The EU Clinical Trials Register currently displays   37700   clinical trials with a EudraCT protocol, of which   6177   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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    EudraCT Number:2007-005725-29
    Sponsor's Protocol Code Number:EGF110656
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-08-13
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    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
    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.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 No
    D. name Tyverb
    D. 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.3.9.3Other 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 progression free survival (PFS) in subjects treated with capecitabine and oxaliplatin (CapeOx) plus lapatinib versus CapeOx plus placebo.
    E.2.2Secondary objectives of the trial
    For both treatment arms:

    -To compare the overall survival (OS) benefit, response rate (RR), and duration of overall response
    -To compare the rate of clinical benefit (as defined by CR+PR+SD)
    -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)

    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

    -Subjects may have had prior surgery for their gastric cancer.
    -Patients must be at least 3 weeks beyond surgery and must have recovered from any related toxicity.

    -More than 5 years since prior chemotherapy for malignancy other than gastric carcinoma
    -Prior neoadjuvant and/or adjuvant chemotherapy for early stage disease is allowed, provided first cancer recurrence occurred more than 6 months after completion of therapy. One line of treatment in this setting is allowed.

    -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) Current active hepatic or biliary disease.

    14) 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

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

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

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

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

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

    20. 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)
    Progression Free Survival (PFS), defined as the time from randomization until the date of progression or death. Date of progression is defined as the date of the first imaging or examination showing disease progression. For patients who are withdrawn from study with no progression, tumor assessments will be continued until progression is documented.
    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. 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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    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 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.1.3Elderly (>=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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 410
    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 Decision2008-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-08
    P. End of Trial
    P.End of Trial StatusOngoing
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