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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43628   clinical trials with a EudraCT protocol, of which   7211   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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    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2011-003553-26
    Sponsor's Protocol Code Number:C-II-009
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-003553-26
    A.3Full title of the trial
    A single arm study in metastatic colorectal cancer patients treated with pharmacokinetically (PK) dose adjusted weekly or biweekly 5-fluorouracil (5-FU) regimes.
    Eine einarmige Studie bei Patienten mit metastasiertem kolorektalem Karzinom (CRC) unter pharmakokinetisch (PK) angepasstem, ein- oder zweiwöchigem 5-Fluorouracil (5-FU) Behandlungsschema.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eine klinische Studie in Patienten mit fortgeschrittenem Darmkrebs welche eine einwöchige- oder zweiwöchige Therapie mit individuell angepasster 5-Fluorouracil Dosierung erhalten.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberC-II-009
    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 SponsorCESAR Central European Society for Anticancer Drug Research-EWIV
    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 supportSaladax Biomedical
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCESAR Central European Society for Anticancer Drug Research-EWIV
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressHanglüssgasse 4/1-3
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1150
    B.5.4Telephone number00431522309312
    B.5.5Fax number00431522309314
    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.2.1.2Country which granted the Marketing AuthorisationGermany
    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 name5-Fluorouracil
    D.3.2Product code 5-FU
    D.3.4Pharmaceutical form 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.3.9.1CAS number 51-21-8
    D.3.9.2Current sponsor code5-FU
    D.3.9.3Other descriptive name5-Fluorouracil
    D.3.9.4EV Substance CodeSUB07721MIG
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 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
    Metastatic colorectal cancer
    metastasiertes kolorektales Karzinom
    E.1.1.1Medical condition in easily understood language
    Fortgeschrittener Darmkrebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal 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 determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l. The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.
    Das Primärziel der C-II-009 Studie ist, mittels Anwendung eines vordefinierten Dosierungsalgorithmus, die 5-FU Konzentration innerhalb der in der Literatur beschriebenen optimalen Area-under-the-curve (AUC) von 20-30 mg*h/l zu halten.
    E.2.2Secondary objectives of the trial
    To determine whether pharmacokinetically-guided dose adjustment of 5-FU is able to reduce treatment-related toxicities.
    Das sekundäre Ziel dieser Studie ist, die Häufigkeit von behandlungsbezogenen Toxizitäten zu reduzieren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (1) Capable of understanding the protocol requirements and risks, and providing written informed consent.
    (2) Patients with histologically confirmed metastatic colorectal cancer.
    (3) ECOG Performance Status (ECOG-PS) status ≤ 2.
    (4) Female or male patients of 18 years of age or older
    (5) Life expectancy > 3 months
    (6) Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (intrauterine device [IUD], oral contraceptive or double barrier method of contraception), and must have a negative serum pregnancy test within 1 week prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active male patients must also use acceptable contraceptive methods (condom).
    (7) An absolute neutrophil count >1.5/nl
    (8) Platelet count > 100/nl.
    (9) Total bilirubin ≤ 2 x upper limit of normal.
    (10) AST and ALT ≤ 2.5 x upper limit of normal, or ≤ 5 x upper limit of normal in case of liver metastases.
    (11) Serum creatinine ≤ 2x upper limit of normal
    (12) Hemoglobin ≥ 9 g/dl (may be corrected by transfusion prior to 5-FU treatment with investigator approval).
    (1) Der Patient muss in der Lage sein, etwaige Risiken sowie die Protokoll-Anforderungen zu verstehen und die Patienteninformation und Einwilligung zu unterschreiben.
    (2) Patienten mit einem histologisch abgesicherten, metastasierenden kolorektalen Karzinom.
    (3) Patienten, welche für eine palliative Erst- oder Zweitlinien Chemotherapie mit 5-FU in Frage kommen.
    (4) ECOG Performance Status (ECOG-PS) Status ≤ 2.
    (5) Weiblicher oder männliche Patienten, welcher zur Zeit der Randomisierung älter als 18 Jahre ist.
    (6) Lebenserwartung von > 3 Monaten.
    (7) Gebärfähige Frauen, (z.B. Prämenopausale Frauen oder nicht chirurgisch sterilisierte Frauen) müssen akzeptable kontrazeptive Methoden (Intrauterinpessar, Orale Kontrazeptiva, Doppelbarrieren Methoden) verwenden, sowie einen negativen Serum-Schwangerschaft Test, innerhalb einer Woche vor dem Beginn der Behandlung, machen. Stillende Patientinnen sind von der Studie ausgeschlossen. Sexuell aktive Männer müssen ebenfalls akzeptable Verhütungsmethoden verwenden (Kondom).
    (8) Eine absolute Zahl der Neutrophilen von > 1,500 cells/ mm3 (= 1.5 G/l; = 1,5/nl)
    (9) Zahl der Thrombozyten > 100/nl.
    (10) Totales Bilirubin ≤ 2 x Obergrenze des Normalbereichs.
    (11) AST und ALT ≤ 2.5 x Obergrenze des Normalbereichs, oder ≤ 5 x Obergrenze des Normalbereichs im Fall von Lebermetastasen.
    (12) Serum Kreatinin ≤ 2x Obergrenze des Normalbereichs.
    (13) Hämoglobin ≥ 9 g/dl (es ist erlaubt den Hämoglobin Wert mittels Transfusion vor der 5-FU Behandlung und nach Genehmigung durch den Prüfarzt zu korrigieren).
    E.4Principal exclusion criteria
    (1) Symptomatic brain metastasis.
    (2) Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study.
    (3) Unwilling or unable to follow protocol requirements or to give informed consent.
    (4) Any treatment with cytotoxic or biologic agents within the 4weeks prior to beginning treatment on this study. At least 4 weeks must have elapsed from any prior surgery or radiation.
    (5) Unresolved toxicity from prior chemotherapy (including approved and experimental drugs) greater than grade I.
    (6) Known Dihydropyrimidine dehydrogenase (DPD) deficiency
    (1) Symptomatische Gehirnmetastasen.
    (2) Schwerwiegende systemische Begleiterkrankungen (z.B. aktive Infektionen), welche in den Augen des Prüfarztes die Sicherheit des Patienten, bzw. dessen Fähigkeit die Studie zu beenden, beeinflusst.
    (3) Der Patient ist unfähig oder unwillens die Protokoll Anforderungen zu verstehen bzw. sein Einverständnis zur Teilnahme an dieser Studie zu geben.
    (4) Behandlung mit zytotoxischen oder biologischen Substanzen innerhalb von 4 Wochen vor Behandlungsbeginn dieser Studie. Operationen bzw. Bestrahlungen müssen mindestens 4 Wochen in der Vergangenheit liegen.
    (5) Fortbestehende ≥ Grad 1 Toxizitäten von vorherigen Chemotherapien (zugelassen oder experimentell).
    (6) Bekannter Dihydropyrimidine Dehydrogenase (DPD) Mangel.
    E.5 End points
    E.5.1Primary end point(s)
    To determine whether pharmacokinetically-guided dose adjustment of 5-FU provides a stable intrapatient dose level of 20-30 mg.h /l.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis will be the comparison of the proportion of patients with AUC within 20 to 30 mg.h/L after the first 5-FU application versus the fourth application.
    E.5.2Secondary end point(s)
    To determine whether pharmacokinetically-guided dose adjustment of 5-FU is able to reduce treatment-related toxicities.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment related toxicities will be assesst throughout the 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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    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
    Last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state80
    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)
    According to local practice.
    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 Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-17
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