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    Summary
    EudraCT Number:2012-003741-15
    Sponsor's Protocol Code Number:MSC_apceth_101/1
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-22
    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 - PEI
    A.2EudraCT number2012-003741-15
    A.3Full title of the trial
    Treatment of Advanced Gastrointestinal Cancer in a Phase I/II trial with modified autologous MSC_apceth_101.
    Open-label, multicentre, phase I/II.
    Behandlung von fortgeschrittenen Tumoren des Gastrointestinaltraktes in einer Phase I/II Studie mit modifizierten autologen MSC_apceth_101.
    Offen, multizentrische Phase I/II.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Advanced Gastrointestinal Cancer in a Phase I/II trial with modified autologous MSC_apceth_101
    Behandlung von fortgeschrittenen Tumoren des Gastrointestinaltraktes in einer Phase I/II Studie mit modifizierten autologen MSC_apceth_101
    A.3.2Name or abbreviated title of the trial where available
    TREAT-ME 1
    A.4.1Sponsor's protocol code numberMSC_apceth_101/1
    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 Sponsorapceth GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportapceth GmbH & Co. KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationapceth GmbH & Co. KG
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressHaidgraben 5
    B.5.3.2Town/ cityOttobrunn
    B.5.3.3Post code85521
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989700 9608178
    B.5.5Fax number+4989700 9608160
    B.5.6E-mails.oellerer@apceth.com
    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.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 nameMSC_apceth_101
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    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 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 Cymeven i.v.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Pharma AG
    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 nameCymeven i.v.
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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
    Patients suffering from advanced, recurrent or metastatic gastrointestinal adenocarcinoma.
    E.1.1.1Medical condition in easily understood language
    Patients suffering from advanced, recurrent or metastatic gastrointestinal adenocarcinoma.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10017991
    E.1.2Term Gastrointestinal neoplasms malignant and unspecified
    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 evaluate the safety and tolerability of MSC_apceth_101
    Die Evaluierung der Sicherheit und Verträglichkeit von MSC_apceth_101
    E.2.2Secondary objectives of the trial
    • Efficacy based on RECIST criteria and on tumor/serum markers
    • Quality of life
    • Wirksamkeit basierend auf den ‘RECIST‘ Kriterien und auf Basis von Tumor- oder Serum-Markern
    • Lebensqualität
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
    Target indications:
    cancer of the esophagus (cTNM: T3NxMx or T4NxMx);
    pancreatic (cTNM: T3NxMx); or
    gastric cancer (cTNM: T3NxMx or T4NxMx); or
    intrahepatic cholangiocellular carcinoma (cTNM: T3NxMx or T4NxMx); or
    metastases due to colorectal cancer (cTNM: TxNxM1).
    The TNM classification should not be older than 4 months.

    2. Premature or scheduled termination of standard therapy (including possible preoperative therapy) due to intolerability / progress / inefficacy or no acceptance by the patient if re-lapses/metastases are measurable by means of imaging techniques. No relapse and no metastases should exceed 5 cm in its maximal diameter.

    3. In case of metastases due to colorectal cancer:
    • Metastases are unresectable
    • The total volume of the liver metastases does not exceed 30 % of the total liver volume
    • In addition to liver metastases lung metastases (as assessed by a radiologists with a minimum diameter of at least 0.5 cm) are allowed, however, not more than 10 with the largest one not exceeding 2 cm in diameter
    • Lymph node metastases are permitted
    • Brain metastases: As long as only one organ is affected by extra-cranial metastases due to colorectal cancer no radio-logical investigation for brain metastases is needed if there are no signs or symptoms suspicious for brain metastases. In case of liver and lung metastases the patient has to be excluded unless a cranial image verifies absence of brain metastases

    4. Patients who have donated bone marrow for the production of MSC_apceth_101 based on a separate approved protocol. MSC_apceth_101 must have been released for the (autologous) use in the same patient.

    5. Progressive disease as clinically assessed by the investigator.

    In addtion:
    A.1 Adequate organ function:
    a. Hb > 9.0 g/dl
    b. WBC > 3,000 cells/µl
    c. Neutrophils >500 /μl
    c. Platelets > 100,000 cells/µl
    d. ALT/AST ≤ 3 ULN
    (or ≤ 5 ULN in case of intrahepatic cholangiocellular carcinoma)
    e. total bilirubin ≤ 1.5 ULN
    (or ≤ 2 ULN in case of intrahepatic cholangiocellular carci-noma)
    f. Creatinine ≤ 2.0 mg/dl
    g.Creatinine clearance ≥ 50 ml/min

    A.2 Anticipated minimal life expectancy of at least 6 months

    A.3 Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment. Medically acceptable methods of birth control are methods with a low failure rate of less than 1% per year; e.g. hormonal contraceptives for at least the 7 days before trial enrolment or an intrauterine device, or double barrier method (male or female condom or diaphragm, in com-bination with a spermicidal gel). All women, including those with tubal ligation, are considered to be of childbearing potential unless they have been postmenopausal for at least 2 years. Hysterectomized women are considered surgically sterile and are not required to use any contraception.
    Males should not participate in a sperm donation program.

    A.4 Ability of patient to understand character and individual consequences of clinical trial

    A.5 Age ≥ 18 years

    A.6 Written informed consent must be available before any study specific procedure is performed
    E.4Principal exclusion criteria
    1. Patients with severe heart diseases (NYHA stage three and four; unstable angina pectoris, or myocardial infarction during the last 8 weeks before Visit 1 (Baseline))

    2. Clinical significant ischemic disease during the last 4 weeks before Visit 1 (Baseline)

    3. Severe lung disease (COPD Grade III, Asthma bronchiale Grade IV, lung fibrosis)

    4. General condition worse than ECOG 2

    5. Symptomatic peritoneal carcinomatosis (e.g. by the presence of ascites)

    6. Symptomatic pleural or pericardial effusion

    7. Serious uncontrolled acute infections less than 3 weeks before Visit 1 (Baseline)

    8. Patients with HCV infection as defined by anti-HCV pos and HCV RNA pos and / or HBV in-fection as defined by anti-Hbc pos and/ or HBV DNA pos

    9. Patients with HIV infection as minimally demonstrated by HIV RNA

    10. Immunodeficiencies or systemic autoimmune diseases (e.g. M. Crohn, Colitis ulcerosa) or known malformations of the gastrointestinal tract

    11. Active infection with HSV (by IgM pos)

    12. Second carcinoma in addition to the underlying carcinoma unless the second carcinoma was curatively and successfully resected more than 5 years ago before Visit 1 (Baseline) (exception: basal cell carcinoma, precancerous conditions)

    13. Use of any immunomodulators

    14. Need for chemotherapy or radiotherapy or cytokine treatment (e.g. interferons, G-CSF or GM-CSF) in the time interval 2 weeks before infusion of MSC_apceth_101 or anticipation of chemo- or radiotherapy during treatment with MSC_apceth_101 and GCV until 2 days after the last administration of GCV

    15. Known dependency on alcohol or other drugs

    16. Patients requiring corticoids in doses above the Cushing threshold

    17. Known liver fibrosis or liver cirrhosis

    18. Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator

    19. Female patient who is pregnant or breast feeding

    20. Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first MSC_apceth_101 dose

    21. Any surgery in the last four weeks before the administration of MSC_apceth_101

    22. History of hypersensitivity to the investigational product or to Ganciclovir, Valganciclovir, Aciclovir or Valaciclovir

    23. Any contraindication to Ganciclovir (see package insert) or the need for the following drugs interacting with Ganciclovir: Probenecid; combination of Imipenem-Cilastatin; Dapson, Pen-tamidin; Flucystosin; Vincristin, Vinblastin, Adriamycin, Amphotericin B; combination of Tri-methoprim and Sulfonamides, Nucleosideanaloga or Hydroxy-urea. This is confined to the time period 14 days prior to Ganciclovir and up to 7 days after termination of Ganciclovir treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints, safety and tolerability of MSC_apceth_101 will be assessed by:
    • Adverse event listings and tables based on MedDRA terms, severity grade, relationship to both study medications and CTC-AE grades
    • Listings for laboratory values. Additionally, descriptive statistics will be provided for laboratory parameters.
    • For all other safety data, listings and descriptive statistics (for continuous variables) or frequency tables (for categorical variables) will be provided.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 months after first treatment with MSC_apceth_101.
    E.5.2Secondary end point(s)
    Secondary endpoints will be
    imaging results obtained by CT or MRT (classified by RECIST criteria),
    laboratory data for tumor and serum markers,
    the overall survival of patients and time to tumor progression.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months after first treatment with MSC_apceth_101.
    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 Yes
    E.6.13.1Other scope of the trial description
    proof of concept
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 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 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 concerned2
    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 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
    The study is completed at the time the last patient enrolled has completed all reasonable investigations of day 56 (2 months). It is the final visit of the study.
    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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    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 state28
    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 - only normal or standard therapy, respectively.
    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 Decision2013-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-27
    P. End of Trial
    P.End of Trial StatusCompleted
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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