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    The EU Clinical Trials Register currently displays   36123   clinical trials with a EudraCT protocol, of which   5939   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2014-001333-88
    Sponsor's Protocol Code Number:ACTION
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-23
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-001333-88
    A.3Full title of the trial
    A phase Ib/II study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma
    Een fase I/II onderzoek naar de verdraagzaamheid en effectiviteit van de medicijncombinatie nab-paclitaxel, capecitabine en oxaliplatin bij de eerstelijnsbehandeling van het gemetastaseerd oesophagus-maagcarcinoom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the addition of Nab-paclitaxel (Abraxane) to capecitabine and oxaliplatin in the first-line treatment of metastastasized oesophagogastric carcinoma
    Onderzoek naar de verdraagzaamheid en effectiviteit van de medicijncombinatie nab-paclitaxel, capecitabine en oxaliplatin bij uitgezaaide slokdarm-maag kanker
    A.3.2Name or abbreviated title of the trial where available
    ACTION
    ACTION
    A.4.1Sponsor's protocol code numberACTION
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportAcademic Medical Center Amsterdam
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportCelgene B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointLyda ter Hofstede
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205668229
    B.5.5Fax number0031206919743
    B.5.6E-mailtrialmedonc@amc.uva.nl
    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 Abraxane
    D.2.1.1.2Name of the Marketing Authorisation holderCelgene Europe Ltd.
    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.3.4Pharmaceutical form Powder for dispersion 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 120
    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) 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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeThe IMP contains an excipient of biological origin, albumin, a non-active stabilizing agent. it is derivated from human blood subject to approved donor screening and product manufacturing processes
    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
    Metastasized oesophagogastric carcinoma
    Gemetastaseerd oesophagus-maagcarcinoom
    E.1.1.1Medical condition in easily understood language
    Generalized oesophagogastric cancer
    Uitgezaaide slokdarm-maagkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: To assess the safety and tolerability of Nab-paclitaxel added to oxaliplatin and capecitabine at their currently optimal doses.

    Phase 2: To determine the anti-tumor activity of Nab-paclitaxel when co-administered with oxaliplatin and capecitabine in patients with irresectable or metastasized oesophagogastric cancer in terms of progression free survival.

    Fase 1: Beoordelen van de veiligheid en verdraagzaamheid van nab-paclitaxel toegevoegd aan oxaliplatin en capecitabine op hun huidige optimale dosering

    Fase 2: Bepaling van de anti-tumor activiteit van nab-paclitaxel wanneer toegediend met oxaliplatin en capecitabine bij patiënten met gevorderd slokdarm-maagkanker in termen van progressievrije overleving.

    E.2.2Secondary objectives of the trial
    Phase 1: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered.
    2. To assess response rate, progression free survival, overall survival.
    3. To assess self-reported neurotoxicity.

    Phase 2: 1. To assess the number of complete cycles of Nab-paclitaxel, oxaliplatin and capecitabine delivered.
    2. To assess response rate, overall survival.
    3. To assess self-reported neurotoxicity.
    Fase 1: 1. Beoordelen van het aantal toegediende cycli nab-paclitaxel, oxaliplatin en capecitabine
    2. Beoordelen van de respons rate, progressievrije overleving en totale overleving
    3. Beoordelen van zelfgerapporteerde neurotoxiciteit

    Fase 2: 1. Beoordelen van het aantal toegediende cycli nab-paclitaxel, oxaliplatin en capecitabine
    2. Beoordelen van de respons rate, progressievrije overleving en totale overleving
    3. Beoordelen van zelfgerapporteerde neurotoxiciteit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female ≥ 18 year
    2. Histological proof of metastastic or irresectable carcinoma of the stomach or oesophagus.
    3. WHO 0-2.
    4. Measureable disease as assessed by RECIST 1.1
    5. Adequate bone marrow and organ function.
    6. Informed consent.

    1. Man of vrouw ≥ 18 jaar
    2. Histologische bewijs van gemetastaseerd of irresectabele carcinoom van de maag of slokdarm.
    3. WHO 0-2.
    4. Meetbare ziekte zoals beoordeeld door RECIST 1.1
    5. Voldoende beenmerg en orgaanfuncties.
    6. Informed consent.

    E.4Principal exclusion criteria
    1. Prior systemic treatment for metastatic or irresectable stomach or oesophageal cancer
    2. All target lesions in a radiation field without documented disease progressionn
    3. WHO 3-4.
    4. Use of other investigational drugs within 30 days of enrollment or 5 half-lives of the study drug, whichever is longer.
    5. CNS metastases or a CNS malignancy.
    6. Other previous malignancies except cervical carcinoma and squamous carcinoma of the skin ≥ 5 years ago
    1. Voorafgaand systemische behandeling voor uitgezaaide of irresectabele maag-of slokdarmkanker
    2. Alle te vervolgen lesies in een stralingsveld zonder gedocumenteerde ziekteprogressie.
    3. WHO 3-4.
    4. Gebruik van andere geneesmiddelen voor onderzoek binnen 30 dagen na de inschrijving of 5 halfwaardetijden van de studie drug, als dat langer is.
    5. CZS metastasen of een CNS maligniteit.
    6. Andere eerdere maligniteiten behalve baarmoederhalskanker en plaveiselcelcarcinoom van de huid ≥ 5 jaar geleden.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: (dose limiting toxicity) and MTD (maximum tolerated dose) of nab-paclitaxel co-administered with fixed doses of capecitabine and oxaliplatin in patients with metastatic or irresectable carcinoma of the stomach or oesophagus.

    Phase 2: Progression free survival
    Fase 1: DLT (dosis-limiterende toxiciteit) en MTD (maximaal getolereerde dosis) van nab-paclitaxel toegediend met vaste doses van capecitabine en oxaliplatin bij patiënten met gevorderd slokdarm-maagkanker

    Fase 2: progressie vrije overleving
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase 1: Continuously during treatment
    Phase 2: Every nine (9) weeks
    Fase 1: Continue gedurende de behandeling
    Fase 2: Elke negen (9) weken
    E.5.2Secondary end point(s)
    Phase 1:
    1. Adverse events, serious adverse events according to NCI CTC version 4.0
    2. Response rate according to RECIST 1.1
    3. Progression free survival and overall survival
    4. Self-reported neurotoxicity according to the EORTC QLQ CIPN2019

    Phase 2:
    1. Adverse events, serious adverse events according to NCI CTC version 4.0
    2. Response rate according to RECIST 1.1
    3. Progression free survival and overall survival
    4. Self-reported neurotoxicity according to the EORTC QLQ CIPN20
    Fase 1:
    1. Bijwerkingen, ernstige bijwerkingen volgens NCI CTC versie 4.0
    2. Respons volgens RECIST 1.1
    3. Progressievrije overleving en algehele overleving
    4. Zelfgerapporteerde neurotoxiciteit volgens de EORTC QLQ CIPN2019

    Fase 2:
    1. Bijwerkingen, ernstige bijwerkingen volgens NCI CTC versie 4.0
    2. Respons volgens RECIST 1.1
    3. Totale overleving
    4. Zelfgerapporteerde neurotoxiciteit volgens de EORTC QLQ CIPN20
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase 1: Continuously during treatment
    Phase 2: everynine (9) weeks
    Fase 1: Continue gedurende de behandeling
    Fase 2: Elke negen (9) weken
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To determine the MTD (maximum tolerated dose) of the IMP
    Om de maximaal toelaatbare dosis te bepalen van de onderzoeksmedicatie
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    Zonder de toevoeging van Nab-paclitaxel (Abraxane)
    Withouth the addition of Nab-paclitaxel (Abraxane)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    LVLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state154
    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)
    None
    Geen
    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 Decision2014-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-16
    P. End of Trial
    P.End of Trial StatusCompleted
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