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    Summary
    EudraCT Number:2021-005874-24
    Sponsor's Protocol Code Number:PEI004/2021
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-02-07
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-005874-24
    A.3Full title of the trial
    Open label randomized, multicentre, controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer
    Ensayo clínico abierto, multicéntrico, aleatorizado y controlado de tratamiento enzimático sustitutivo (TES) de insuficiencia pancreática exocrina (IPE) en pacientes con cáncer de páncreas irresecable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy of the oral treatment with pancreatic enzymes in patients with pancreatic cancer, who are not suitable for surgical therapy.
    Ensayo clínico para evaluar el impacto del tratamiento oral con enzimas pancreáticas en pacientes con cáncer de páncreas que no son candidatos a intervención quirúrgica.
    A.3.2Name or abbreviated title of the trial where available
    PERT for PEI in pancreatic cancer
    TES para IPE en cáncer de páncreas
    A.4.1Sponsor's protocol code numberPEI004/2021
    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 SponsorJuan Enrique Domínguez Muñoz
    B.1.3.4CountrySpain
    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 supportViatris
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJuan Enrique Domínguez Muñoz
    B.5.2Functional name of contact pointDepartment of Gastroenterology
    B.5.3 Address:
    B.5.3.1Street AddressTravesía de Choupana s/n
    B.5.3.2Town/ citySantiago de Compostela
    B.5.3.3Post code15706
    B.5.3.4CountrySpain
    B.5.4Telephone number34981951364
    B.5.5Fax number34981955100
    B.5.6E-maildig.chus.santiago@sergas.es
    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 Creon 35,000
    D.2.1.1.2Name of the Marketing Authorisation holderMylan IRE Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCreon / Kreon 35000
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKreon
    D.3.9.1CAS number 8049-47-6
    D.3.9.3Other descriptive namePANCREATIN
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number455000
    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
    pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
    E.1.1.1Medical condition in easily understood language
    controlled trial of pancreatic enzyme replacement therapy (PERT) for pancreatic exocrine insufficiency (PEI) in patients with unresectable pancreatic cancer.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    the primary objective of the study is to evaluate the impact of PERT on body weight in patients with PEI secondary to unresectable pancreatic cancer.
    E.2.2Secondary objectives of the trial
    Secondary aim is to evaluate the impact of PERT on:
    - Nutritional status
    - Karnofsky performance status.
    - Abdominal symptoms.
    - Quality of life.
    - Tolerance to chemotherapy.
    - Survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years, any gender, fulfilling the following criteria will be considered for the study:
    1. Unresectable, locally advanced or metastatic, pancreatic cancer.
    2. Tumour located in the head of the pancreas.
    3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
    4. Significant weight loss (≥5% of the usual body weight).
    5. Life expectancy of at least six months at screening.
    6. Signed informed consent to the study.
    E.4Principal exclusion criteria
    1. Patients with indication of neoadjuvant chemotherapy.
    2. History of pancreatic or gastric surgery.
    3. Short life expectancy (shorter than 6 months).
    4. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy) at inclusion.
    5. Patients in whom a pancreatic stent has been placed.
    6. Unsolved gastric outlet obstruction.
    7. Known allergy to porcine proteins.
    8. Unwillingness to participate in the study.
    9. Inability to comply with the study visits and study protocol, whatever the reason.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is defined as the change in body weight (kg and percentage)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over 3 and 6 months from inclusion.
    E.5.2Secondary end point(s)
    - Change in haemoglobin, lymphocytes, serum concentration of nutritional markers (albumin, prealbumin, retinol binding protein, transferrin, fat-soluble vitamins, total and HDL cholesterol, triglycerides, cholinesterase, magnesium, selenium, and zinc) and HbA1C.
    - Change in Karnofsky performance status from baseline to the end of the controlled phase and the end of the study in the two groups of patients.
    - Change in malabsorption-related symptoms (diarrhoea, flatulence, abdominal distention, meteorism, abdominal cramps) and Patient-Generated Subjective Global Assessment (PG-SGA).
    - Change in quality of life (EORTC QLQ-PAN26).
    - Tolerance to chemotherapy defined as the percentage of the optimal dose of chemotherapeutic agents administered.
    - Survival.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 3 and 6 months from inclusion.
    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 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) 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) 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 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 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 trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    France
    Spain
    Sweden
    United Kingdom
    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
    LVLS
    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 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: 60
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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)
    This protocol (visits and clinical evaluation) does not differ from clinical 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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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