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    Summary
    EudraCT Number:2007-000924-42
    Sponsor's Protocol Code Number:LAPADO-Study
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-05-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000924-42
    A.3Full title of the trial
    Phase I/II-Studie zur neoadjuvanten Chemotherapie mit nicht-pegyliertem liposomalem Doxorubicin, Paclitaxel und Lapatinib bei Patientinnen mit HER2-überexprimierenden, primärem Mammakarzinomen
    A.4.1Sponsor's protocol code numberLAPADO-Study
    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 SponsorSana Klinikum Lichtenberg
    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 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 Taxomedac 6mg/ ml
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie B.V
    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 nameTaxomedac
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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.IMP: 2
    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 Myocet
    D.2.1.1.2Name of the Marketing Authorisation holderZeneus Pharma
    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 nameMyocet
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNLiposomaler Doxorubicin-Citrat-Komplex
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    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 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 mg milligram(s)
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Im Rahmen der klinischen Studie soll eine Chemotherapie, die aus den Medikamenten nicht-pegyliertes liposomales Doxorubicin, Paclitaxel und Lapatinib besteht, verabreicht werden. Das Ziel dieser klinischen Studie ist es, die Wirksamkeit und Verträglichkeit der Kombinationsbehandlung mit den drei Medikamenten in verschiedenen Dosierungen bei Patientinnen mit einem primären Mammakarzinom zu überprüfen.
    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
    Primäre Studienziele:
    • Ermittlung der optimalen Dosierungen von nicht-pegyliertem liposomalem Doxorubicin, Paclitaxel und Lapatinib (Phase I)
    • Ermittlung der Rate pathologisch gesicherter Vollremissionen (pCR) unter neoadjuvanter Chemotherapie mit nicht-pegyliertem liposomalem Doxorubicin, Paclitaxel und Lapatinib (Phase II)
    E.2.2Secondary objectives of the trial
    Sekundäre Studienziele:
    • Ermittlung der Sicherheit und Verträglichkeit der Studienbehandlung
    • Untersuchung der Inzidenz kardialer Ereignisse unter der Studienbehandlung
    • Ermittlung der Rate der im Anschluß an die Chemotherapie brusterhaltend operierten Patientinnen
    • Ermittlung des klinischen Tumoransprechens
    • Ermittlung des krankheitsfreien Überlebens und des Gesamt-überlebens
    Tertiäre Studienziele:
    • Untersuchung vordefinierter molekularer Parameter bzw. Zielgene in Hinblick auf die Sensitivität oder Resistenz gegenüber der Studientherapie
    • Charakterisierung und Evaluierung nicht vordefinierter molekularer Veränderungen bezüglich der Sensitivität gegenüber der Studientherapie
    • Charakterisierung und Evaluierung spezifischer, molekular definierter Untergruppen bezueglich der Praediktion des Therapieerfolgs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational Study

    Im Rahmen der Studie ist eine genaue Untersuchung prognostischer und prädiktiver Faktoren geplant, mit deren Hilfe herausgefunden werden soll, welche Patientinnen den optimalen Nutzen von der Therapie erfahren. Des weiteren wird untersucht werden, welche Mechanismen bei einer möglichen Resistenzentwicklung eine Rolle spielen. Diese wissenschaftlichen Begleituntersuchungen werden sowohl an Gewebeproben, als auch an Blut- und Urinproben durchgeführt werden und beinhalten genetische Untersuchungen. Dafür werden vor Studienbeginn, vor jedem Therapiezyklus und im Rahmen der Nachsorge jeweils ca. 10-15 ml Blut bzw. Urin asserviert. Die Gesamtmenge wird während der Behandlungsphase insgesamt maximal 100 ml betragen. Zudem werden an der bei Ihnen bereits entnommenen Gewebeprobe und an dem bei der abschliessenden Operation entnommenen Gewebe weitere Untersuchungen vorgenommen werden.
    Darüber hinaus soll nach 2 Zyklen eine zusätzliche Biopsie des Primärtumors vornehmen. Diese Untersuchung würde wertvolle Einblicke in die durch die Therapie ausgelösten Vorgänge im Tumorgewebe liefern. Dies soll nicht zuletzt dazu dienen, die Therapie zukünftig zielgerichteter durchführen zu können.
    E.3Principal inclusion criteria
    Patienten können nur dann an der Studie teilnehmen, wenn sie alle der nachfolgenden Kriterien erfüllen:
    • Histologisch gesichertes Mammakarzinom
    • Stadium T1c N1-2 oder T2 N0-2
    • HER2-positiver Tumors mit einem Immunhistochemischem Score von 3+ oder Nachweis einer Amplifikation der HER2 Gens mittels Fluorescence in situ hybridisierung (FISH)
    • Keine systemische Vortherapie
    • Ausreichende Knochenmarkreserve: Neutrophilenzahl (ANC) * 1.5 x 109/L, Thrombozytenzahl * 100 X 109/L, Hämoglobin * 80 g/L.
    • Ausreichende Nierenfunktion (Serumkreatinin <1,5-faches des oberen Normwerts, Kreatininclearance >60 mL/min)
    • Bilirubin <1,5-faches des oberen Normwerts
    • AST (SGOT)/ALT(SGPT)  2.5- faches des oberen Normwerts
    • Normale kardiale Funktion mit einer linksventriuklären Auswurffraktion von mindestens 50% (gemessen mittels Echokardiographie oder nuklearmedizinisch)
    • Performance-Status von 80 oder höher auf der Karnofsky-Skala.
    • Alter  18Jahre
    • Frauen in gebärfähigem Alter müssen für eine ausreichende Kontrazeption während der Studie sorgen und einen negativen Schwangerschaftstest innerhalb von einer Woche vor Therapie-beginn aufweisen
    • Schriftliche Einwilligungserklärung der Patientin.
    E.4Principal exclusion criteria
    Patienten sind von der Studie auszuschließen, wenn eines der im folgenden genannten Kriterien zutrifft:
    • Männer mit Mammakarzinom
    • Inflammatorisches Mammakarzinom
    • Nachweis einer Fernmetastasierung
    • Vorangegangene systemische oder lokale Therapie des Mammakarzinoms (einschließlich Operation, Radiatio, Chemo-therapie oder endokrine Therapie)
    • Weitere aktuelle oder zurückliegende maligne Erkrankung (ausgenommen In-situ-Karzinom der Zervix, adäquat behandeltes Basalzellkarzinom der Haut oder andere Karzinomerkrankung, die in kurativer Intention behandelt wurde und bei der seit mindestens 5 Jahren Krankheitsfreiheit besteht).
    • Schwerwiegende kardiale Erkrankung inklusive Angina pectoris, schwere Arrhythmien (die eine medikamentöse Therapie notwendig machen), schwere Erkrankungen des Erregungsleitungssystems, klinisch relevante Klappenerkrankungen, Kardiomegalie, ventrikuläre Hypertrophie, inadäquat kontrollierte Hypertonie (diastolischer Blutdruck in Ruhe >115 mmHg), Zustand nach Myokardinfarkt, Herzinsuffizienz oder andere Kadiomyopathie
    • Aktuelle aktive Leber-oder Gallenwegs Krankheiten (mit Ausnahme von Patienten mit Gilbert-Syndrom, asymptomatische Gallensteine, Lebermetastasen oder stabilen chronischen Lebererkrankung)
    • Vorbestehende sensorische or motorische Polyneuropathie  Grad 2 entsprechend NCI CTC
    • Schwerwiegende Begleiterkrankungen inklusive psychiatrischer Erkrankungen oder schweren, aktiven Infektionen
    • Gleichzeitige Behandlung mit anderen experimentellen Substanzen. Teilnahme an einer anderen intervenionellen klinischen Studie innerhalb von 30 Tagen vor Studieneinschluss
    • Schwangerschaft oder Stillzeit
    • Personen, die aufgrund behördlicher oder gerichtlicher Anordnungen in einer Anstalt untergebracht wurden
    E.5 End points
    E.5.1Primary end point(s)
    Der primäre Endpunkt ist die Ermittlung der Rate pathologisch gesicherter Vollremissionen (pCR) unter der neoadjuvanten Therapie. Die pCR-Rate umfasst alle Patientinnen des Phase II Studienteils und die Patientinnen des Phase I Teils, die mit den im Phase II verwendeten Dosierungen behandelt werden. Die Ergebnisse von Patientinnen, die auf anderen Dosisstufen behandelt werden, werden getrennt angegeben.
    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) Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned10
    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 Information not present in EudraCT
    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
    Patients will be informed that they have the right to withdraw from the study at any time for any reason, without prejudice to their medical care. The investigator also has the right to withdraw patients from the study for any of the following reasons:
    • Intercurrent illness
    • Occurrence of any grade 4 non-haematologic toxicity or an unacceptable adverse event (please refer to 3.5.1.)
    • Treatment delay >2 weeks because of toxicity
    • Patient request
    • Protocol violations
    • ...
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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 No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-05-09. Yes
    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 state100
    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 Decision2007-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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