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    Summary
    EudraCT Number:2012-004429-26
    Sponsor's Protocol Code Number:Atu027-I-02
    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:2012-12-28
    Trial results View 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 number2012-004429-26
    A.3Full title of the trial
    A Phase Ib/IIa study of combination therapy with Gemcitabine and Atu027 in subjects with locally advanced or metastatic pancreatic adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An early phase clinical study to investigate the combination of chemotherapy (Gemcitabine) and the study drug Atu027 in patients with advanced or metastatic pancreas cancer
    A.3.2Name or abbreviated title of the trial where available
    Atu027-I-02
    A.4.1Sponsor's protocol code numberAtu027-I-02
    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 SponsorSilence Therapeutics GmbH
    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 supportSilence Therapeutics GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSilence Therapeutics GmbH
    B.5.2Functional name of contact pointDirector Project Management
    B.5.3 Address:
    B.5.3.1Street AddressRobert-Rössle-Str. 10
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13125
    B.5.3.4CountryGermany
    B.5.6E-mailF.Gebhardt@silence-therapeutics.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.3.2Product code Atu027
    D.3.4Pharmaceutical form Concentrate for 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.3.8INN - Proposed INNn.a.
    D.3.9.1CAS number n.a.
    D.3.9.2Current sponsor codeATU-RNA 027/23H
    D.3.9.3Other descriptive nameATU-RNA 027/23H
    D.3.9.4EV Substance CodeSUB91227
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.43
    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
    Locally advanced or metastatic pancreatic adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Advanced tumor of the pancreas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033600
    E.1.2Term Pancreatic adenocarcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to evaluate the safety and pharmacokinetics of Atu027 when used in combination with gemcitabine in subjects with locally advanced or metastatic pancreatic adenocarcinoma.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study will be to evaluate the efficacy of Atu027 when used in combination with gemcitabine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Lead-in safety period:
    1. Subjects between the age of 18 and 84 years
    2. Histologically or cytologically confirmed advanced or refractory cholangiocellular carcinoma, biliary tract cancer, non-small-cell lung carcinoma, duodenal cancer, soft tissue sarcoma, ovarian carcinoma, or another non-pancreatic cancer disease indicated for gemcitabine treatment as determined by the investigator
    3. Subjects who have previously received chemotherapy and standard curative or palliative care is not available, not effective, or unlikely to be effective
    4.No option for surgical resection or radiation in curative intent
    5.Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 – 2
    6.Life expectancy of at least 3 months
    7.No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
    8.Alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN; ≤5 x ULN for subjects with liver metastases)
    9.Aspartate aminotransferase (AST) ≤3.0 x ULN (≤5 x ULN for subjects with liver involvement with cancer)
    10.Total bilirubin ≤2.0 x ULN (liver metastasis <5 x ULN)
    11.Serum creatinine ≤1.5 x ULN
    12.Adequate bone marrow function: subjects should have an absolute granulocyte count of at least 1,500 (x 106/L) and platelet count of 100,000 (x 106/L) prior to the initiation of a cycle.
    13.Prothrombin time-international normalized ratio/partial thromboplastin time (PT-INR/PTT) <1.5 x ULN (subjects who are being therapeutically anti-coagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists). Low-dose aspirin is permitted (≤100 mg daily).
    14. Women of childbearing potential must have a negative urine pregnancy test at baseline.
    15. Women of childbearing potential and men must be willing to use highly effective contraceptive methods during the course of the study and 6 months after.
    16. Subjects must be willing and able (in the opinion of the investigator) to understand the subject information and informed consent form and to comply with the study protocol and procedures.
    17. Subjects must be willing and able to give written informed consent.

    Main part:
    1.Subjects between the age of 18 and 84 years
    2.Locally advanced or metastatic pancreatic adenocarcinoma stage III/IV
    3.No option for surgical resection or radiation in curative intent
    4.Histological or cytological documentation of non-hematologic, malignant solid tumor
    5.At least one measurable lesion or evaluable disease, as per the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1
    6.Eastern Cooperative Oncology Group (ECOG) performance status assessment of 0 to 2
    7.Life expectancy of at least 3 months
    E.4Principal exclusion criteria
    Lead-in safety period:
    1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
    2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) ≥7%
    3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management
    4. Poorly controlled seizure disorder
    5. Subjects undergoing renal dialysis
    6. Known hypersensitivity to the study drugs or active substances or excipients of the preparations
    7. Pregnant or breast feeding
    8. Known hepatitis B or C or human immunodeficiency virus (HIV) infection (if documented in the subject’s record)
    9. Previous participation in this study
    10. Current or previous (within 30 days of enrolment) treatment with another investigational drug or participation in another clinical study.
    11. Subject is a relative of, or staff directly reporting to the investigator.
    12. Subject is an employee of the sponsor.
    13. Subject is committed under official or judicial order.
    14. Any other reason that the investigator considers makes the subject unsuitable to participate

    Main part:
    1. History of cardiac disease; congestive heart failure >New York Heart Association (NYHA) functional classification system Class II; active coronary artery disease, myocardial infarction within 6 months prior to study entry; new onset angina within 3 months prior to study entry or unstable angina, or ventricular cardiac arrhythmias requiring anti-arrhythmic therapy
    2. Poorly controlled diabetes defined as hemoglobin A1c (HbA1c) ≥8%
    3. Poorly controlled hypertension, defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management
    4. Poorly controlled seizure disorder
    5. Subjects undergoing renal dialysis
    6. Anticancer chemotherapy or immunotherapy during the study or before first study treatment. Subjects with recurrent disease after adjuvant treatment not progression-free for at least 6 months.
    7. Radiotherapy to target lesions during study or before study start
    E.5 End points
    E.5.1Primary end point(s)
    No formal primary or secondary endpoints will be defined. However, safety and PK variables will be of primary interest. Safety (Physical examination, Vital signs, Body weight,12-lead electrocardiogram (ECG; including QTc) Clinical laboratory parameters including hematology, clinical chemistry, and urinalysis)
    Pharmacokinetics
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and Pharmacokinetics assessments will be done throughout the study
    E.5.2Secondary end point(s)
    Secondary variables: Objective response rate: response will be assessed by RECIST Version 1.1, Progression-free survival, Overall survival, ECOG performance score, Biomarker response), Tumor marker response, Quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response related outcome assessments will be done 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 Yes
    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
    Safety assessment
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Randomisation not against placebo but to one of the two treatment arms, both with IMP.
    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 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 end of the study is defined as the date of the last follow-up visit of the last subject in any participating center.
    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 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 state27
    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)
    After the end of treatment, subjects may be given the opportunity to get further treatment with Atu027.
    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 Decision2013-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-05
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