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    Summary
    EudraCT Number:2005-000666-39
    Sponsor's Protocol Code Number:CT 4001
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-12-01
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-000666-39
    A.3Full title of the trial
    A Controlled, Randomized, Open label Phase II Trial to Evaluate Safety and Efficacy of a 1st line Combination Treatment with Weekly Infusion of Gemcitabine and Twice Weekly Administration of Lipid Complexed Paclitaxel (EndoTAG®-1) in Three Dose Levels Compared with Gemcitabine Monotherapy in Patients with Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberCT 4001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorMediGene AG
    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 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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/06/419
    D.3 Description of the IMP
    D.3.1Product nameEndoTAG-1
    D.3.2Product code EndoTAG-1
    D.3.4Pharmaceutical form Powder 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.3.9.2Current sponsor codeMDG.09.100
    D.3.9.3Other descriptive nameSemi-synthetic Paclitaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    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 RoleComparator
    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.2.1.1.2Name of the Marketing Authorisation holderElli Lilly ČR s.r.o. Prague, Czech Republic
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation numberEU/3/06/419
    D.3 Description of the IMP
    D.3.1Product nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGemcitabine
    D.3.9.1CAS number 122111-03-9
    D.3.9.2Current sponsor codeGemcitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Measurable Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10052747
    E.1.2Term Adenocarcinoma pancreas
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety Objectives:
    - Assessment of the safety of biweekly infusions of EndoTAG™-1 and weekly infusions of gemcitabine via:
    - Incidence and percentage with patients EndoTAG™-1 and gemcitabine related AE
    - Laboratory abnormalities (hematology, coagulation parameters, clinical chemistry, urine analysis)
    - Dose reductions, pausing and/or discontinuations of EndoTAG™-1 and/or gemcitabine

    Efficacy Objectives:
    - Assessment of survival (progression free survival, 6-month survival rate, overall survival)
    - Tumor response evaluation after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine, i.e. 1 week after last treatment and according to follow-up plan
    - Clinical Benefit Assessment via Quality of Life (QoL) Scale (EORTC-QoL-C30-Questionnaire, PAN-26-module)
    - Assessment of clinical status via ECOG Scale
    E.2.2Secondary objectives of the trial
    none
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    - Written informed consent
    - histologically or cytologically confirmed pancreatic adenocarcinoma suitable for chemotherapy
    - clinical diagnosis of irresectable pancreatic adenocarcinoma
    - ECOG performance status 0, 1 or 2
    - ≥ 18 years old
    - negative pregnancy test (females of childbearing potential)
    - willingness to perform double-barrier contraception during study and for 6 months post chemotherapy treatment
    E.4Principal exclusion criteria
    - Cardiovascular disease, New York Heart Association (NYHA) III or IV
    - History of severe supraventricular or ventricular arrhythmia
    - History of coagulation or bleeding disorder (PTT > 1.5 x ULN)
    - Severe pulmonary obstructive or restrictive disease
    - Diabetic retinopathy
    - Acute or chronic inflammation (autoimmune or infectious)
    - Significant active / unstable non-malignant disease likely to interfere with study assessments
    - Laboratory tests (hematology, chemistry) outside specified limits:
    - WBC ≤ 3 x 1000/ mm3
    - ANC ≤ 1.5 x 1000/mm3
    - Platelets ≤ 100.000 / mm3
    - Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    - PT/PTT > 1.5 x ULN
    - Serum creatinine > 2.0 mg/dl (> 176.8 mmol/l)
    - AST and/or ALT > 5 x ULN
    - Alkaline phosphatase > 2 x ULN
    - Total bilirubin > 2 x ULN
    - Immunotherapy < 6 weeks prior to enrollment
    - Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
    - Any radiotherapy for pancreatic adenocarcinoma before enrollment except for treatment of bone metastases if target lesions are not included in the irradiated field
    - Major surgery < 4 weeks prior to enrollment
    - Pregnant or nursing
    - Investigational medicinal product < 4 weeks of enrollment
    - HIV history
    - Hypersensitivity to any component of the EndoTAG™-1 and/or gemcitabine formulations
    - History of significant liver pathology (other than metastases)· History of malignancy other than pancreatic cancer < 5 years prior to enrollment, except skin cancer treated locally
    - Vulnerable populations (e.g. subjects incapable of giving consent personally
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints

    - Median progression free survival (PFS)
    - 6-month-survival-rate calculated by the rate of patients alive 6 months after start of treatment
    - Median overall survival (OS)
    - Tumor Response (CR / PR / SD / PD) after 14 applications of EndoTAG™-1 and 7 applications of gemcitabine (1 cycle) assessed by the following variables: CT/MRI scans, chest X-ray and CA19-9 level kinetics
    - Clinical Benefit via Assessment of Quality of Life (QoL): EORTC-QoL-C30-Questionnaire + PAN-26-module
    - Pain assessment (Visual analogue scale = VAS)
    - ECOG: Number of patients with improvement/ steady state/ deterioration at week 8 compared to baseline
    - CA 19-9: Number of subjects with increase/no change/decrease between baseline and end of treatment, number of subjects within the normal range at baseline and at end of treatment

    Safety endpoints
    - Adverse Events: Incidence and percentage of patients with treatment emergent AEs
    - Laboratory Values: Number of clinically significant abnormal laboratory values
    - Dose variations: Percentage of patients having dose reductions/ pausing or discontinuations of gemcitabine and/or EndoTAG™-1

    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 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.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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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 Out
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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 2005-12-01. 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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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)
    Amendment 4 changes the protocol to allow patients in arms 2-4 with response or stable disease at End of Treatment to continue receiving EndoTAG-1 in the same regimen until disease progression.
    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 Decision2005-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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