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    Summary
    EudraCT Number:2010-024289-24
    Sponsor's Protocol Code Number:2010-024289-24
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-09-19
    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 ConcernedNorway - NOMA
    A.2EudraCT number2010-024289-24
    A.3Full title of the trial
    TREATMENT OF PANCREATIC ADENOCARCINOMA BY COMBINING CONTRAST AGENT AND GEMCITABINE UNDER SONICATION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ultrasound-assisted treatment of inoperable pancreatic cancer.
    ”Behandling av inoperabel kreft i bukspyttkjertelen ved å kombinere kontrast ultralyd og gemcitabin under sonoporering”
    A.3.2Name or abbreviated title of the trial where available
    CEUS treatment
    A.4.1Sponsor's protocol code number2010-024289-24
    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 SponsorHelse Bergen HF, Haukeland Unversity Hospital
    B.1.3.4CountryNorway
    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 supportHaukeland Unversity Hospital
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelse Bergen HF, Haukeland Unversity Hospital
    B.5.2Functional name of contact pointGeorg Dimcevski
    B.5.3 Address:
    B.5.3.1Street AddressJonas Lies vei 65
    B.5.3.2Town/ cityBergen
    B.5.3.3Post code5021
    B.5.3.4CountryNorway
    B.5.4Telephone number+4755972872
    B.5.5Fax number+4755972950
    B.5.6E-mailgeorg.dimcevski@helse-bergen.no
    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 Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameGemzar
    D.3.4Pharmaceutical form Powder and solvent for concentrate 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.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 SonoVue
    D.2.1.1.2Name of the Marketing Authorisation holderBracco S.P.A. Milano, Italia
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameSonoVue
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 with inoperable pancreatic cancer.

    Histologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas.

    The patients must be ambulatory with an ECOG performance status 0-2.
    E.1.1.1Medical condition in easily understood language
    Patients with inoperable pancreatic cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    • To evaluate the safety of the combined (Gemcitabine/US contrast agent under sonication) treatment.
    E.2.2Secondary objectives of the trial
    Exploratory endpoints:
    • To evaluate the gemcitabine chemotherapeutic drug uptake in plasma and blood mononuclear cells in patients with inoperable tumors.
    • To quantify gemcitabine and its main metabolites in plasma and in circulating mononuclear cells before, during and after pancreatic sonication, and to quantify the concentration of intracellular endogenous nucleotides in circulating mononuclear cells at the same time points.
    • To evaluate the effects on serum CA 19-9 concentrations.
    • To evaluate and compare the toxic effects of gemcitabine in combination with US contrast agent under sonication with gemcitabine alone in historical controls.
    • Clinical benefit response, which is a measure of clinical improvement based on analgesic consumption, ECOG performance status, and weight change.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with inoperable pancreatic cancer (ICD-10 C25.0–3) at the Department of Surgical Gastroenterology of Haukeland University Hospital, who have volunteered to participate, will be included.

    Patients, who meet all the following inclusion criteria, are eligible for the study entry:
    • Patient must be > 18 years of age, inclusive.
    • Patient has a diagnosis of inoperable pancreatic cancer
    o (ICD-10 C25.0 Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas and C25.3 Malignant neoplasm: Pancreatic duct).
    • Histologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas. •
    • Must be ambulatory with an ECOG performance status 0-2
    • Female patients of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) one of the following forms of contraception from the Screening Visit until completion of the first study follow-up visit: hormonal (oral, implant or injection) begun > 15 days prior to the Screening Visit, barrier (e.g., condom, diaphragm with spermicide), intra-uterine device or vasectomised partner (6 months minimum). If required by the Local Ethics Committee, male patients must also agree to practice throughout the study an approved method of birth control.
    [Note: To be considered NOT of child-bearing potential, female patients must be postmenopausal (with amenorrhea for at least 2 years prior to study entry) or surgically sterile (with physician or insurance documentation of bilateral tubal ligation at least 6 months prior to study entry, or of a hysterectomy and/or bilateral oophorectomy).]
    • Must have lab values as the following: Hemoglobin > 10, neutrophils (polymorphonuclear leukocytes) > 3.5, PLT > 150 and Bilirubin < 75.
    • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    • Patient participated in an investigational study within 30 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).
    • Patient has severe chronic obstructive pulmonary disease or severe chronic asthma.
    • Patient has a history of cardiovascular ischemia, acute myocardial infarction or unstable angina within 3 months prior to study entry.
    • Patient has a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
    • Patient has a known history of Hepatitis B, Hepatitis C or HIV infection.
    • Patient requires dialysis or has severely impaired renal function, defined as a serum creatinine > 180 mmol/L at the Screening Visit.
    • Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the upper limit of normal) at the Screening Visit.
    • Patient is pregnant or is breast-feeding.
    • Patient is allergic to or intolerant of gemcitabine
    • Patient is allergic to or intolerant of SonoVue® BRACCO ultrasound contrast agent
    • Any reason why, in the opinion of the investigator, the patient should not participate.
    E.5 End points
    E.5.1Primary end point(s)
    Abdominal US with contrast agents to quantify tumour size will be used at each visit.
    A PET /CT scan will be performed before treatment, in order to verify locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas and at the follow-up visits.
    To evaluate the effects on serum CA 19-9 concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 8th week while on treatment. After the study period every 3rd month until progression or death is documented.
    E.5.2Secondary end point(s)
    Survival will be monitored.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every third week.
    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 Yes
    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
    Combination of gemcitabine and ultrasonography contrast given sequentially.
    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 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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Trial Discontinuation
    • Occurrence of AEs unknown to date in respect of their nature, severity and duration
    • Medical or ethical reasons affecting the continued performance of the trial
    • Difficulties in the recruitment of patients
    The sponsor and principal investigator will promptly inform all investigators and the relevant regulatory authorities of the termination of the trial along with the reasons for such action.
    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 months6
    E.8.9.1In the Member State concerned days30
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 10
    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)
    Not different from the expects normal treatment condition.
    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 Decision2012-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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