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    Summary
    EudraCT Number:2019-001200-38
    Sponsor's Protocol Code Number:OTIS2019_001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-01-20
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-001200-38
    A.3Full title of the trial
    Octreotide treatment to improve nutritional recovery after surgery for patients with esophageal or gastric cancer, a prospective randomized open label phase II study - OTIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is it possible to improve the nutritional recovery with a medicine called Sandostatin after surgery for esophageal or gastric cancer?
    A.3.2Name or abbreviated title of the trial where available
    OTIS
    A.4.1Sponsor's protocol code numberOTIS2019_001
    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 SponsorKarolinska Universitetssjukhuset
    B.1.3.4CountrySweden
    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 supportKarolinska Universitetssjukhuset, FoU-enheten PO övre buk B75
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Universitetssjukhuset, FoU-enheten PO övre buk B75
    B.5.2Functional name of contact pointFoU-enheten PO Övre Buk B75
    B.5.3 Address:
    B.5.3.1Street AddressHälsovägen 13
    B.5.3.2Town/ cityHuddinge
    B.5.3.3Post code14186
    B.5.3.4CountrySweden
    B.5.4Telephone number004608585 86933
    B.5.6E-mailfredrik.klevebro@ki.se
    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 Sandostatin LAR 10mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Sverige AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 79517-01-4
    D.3.9.3Other descriptive nameOCTREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB03490MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Undesired weight loss after operation for esophageal or gastric cancer
    E.1.1.1Medical condition in easily understood language
    Undesired weight loss after operation for esophageal or gastric cancer
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10027415
    E.1.2Term Metabolic abnormality management
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if intramuscular administered Octreotide can decrease weight loss after gastrectomy or esophagectomy due to cancer.
    E.2.2Secondary objectives of the trial
    •To study if octreotide treatment affects the levels of gastrointestinal satiety hormones
    •To determine if octreotide treatment affects body composition
    •To determine if octreotide treatment affects postoperative health related quality of life
    •To study if postoperative eating problems can be reduced by intramuscular administration of octreotide
    •To study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Same title as main study.

    Substudy 1 is a non randomized pilot study, examining 20 patients of which 10 after gastrectomy and 10 after esophagectomy, all receive octreotide treatment (3 monthly doses of 10 mg).

    The primary objective is to study safety and tolerability of treatment with intramuscularly administered octreotide after gastrectomy or esophagectomy due to cancer
    E.3Principal inclusion criteria
    •Pathologic anatomic analysis (PAD) confirmed esophageal or gastric cancer
    •Gastrectomy or esophagectomy with curative intent
    •≥18 years of age
    •Signed informed consent
    •Able to comply with the procedures of the study protocol, in the opinion of the investigator
    •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. Acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly. A negative pregnancy test is required for participation.
    E.4Principal exclusion criteria
    •Non-radical operation (defined by macroscopic assessment) or metastatic disease diagnosed at the time of surgery
    •Complications leading to restrictions in postoperative oral intake
    •Advanced comorbidity with ASA score III or more
    •Bradycardia (defined as resting heart rate of under 60 beats per minute)
    •Chronic obstructive pulmonary disease
    •Chronic liver disease
    •Insulinoma
    •Kidney failure
    •Concomitant medication with: cyclosporine, cimetidine, bromocriptine, quinidine, or terfenadine.
    •Known or suspected allergy to octreotide
    •Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of study participation
    •Pregnant or nursing female
    •Participation or recent participation in a clinical study with an investigational product (within the last 3 months). Previous participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    •Weight loss in percent (%) from baseline weight before surgery, measured at 1, 2, 3, and 6 months after surgery (continuously).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1,2,3 and 6 months after surgery
    E.5.2Secondary end point(s)
    •Measurement of S-GLP-1, S-PYY, S-Ghrelin and S-GIP (prior to octreotide administration), measured at baseline, 7 days (±2 days) post-surgery and after 1 (±4 days), 2(±4 days), 3(±4 days), and 6 (±4 days) months.
    •Body composition measured in percent (%) body fat (continuously) and with the questionnaires PG-SGA and EORTC CAX24.
    •Health-related Quality of Life (HRQOL) measured using EORTC QLQ-C30 and QLQ-OG25, including esophageal cancer specific symptoms, at baseline and at 1, 2, 3 and 6 months after randomization.
    •Percentage (of subjects) in need of enteral nutrition with a jejunostomy feeding catheter or nasogastric tube.
    •Number and type of Adverse Events, including known AEs of Sandostatin LAR depot, such as biliary abnormalities, injection-site pain, nausea, abdominal pain, fatigue, headache, hyperglycemia, back pain, constipation or vomiting, dizziness, sinus bradycardia, pruritus, upper respiratory tract infection, myalgia, flatulence, arthropathy, rash, generalized pain, sinusitis, conduction abnormalities, hypoglycemia, and arrhythmia.
    •Number of patients completing treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1,2,3 and 6 months after surgery
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No treatment with Sandostatin LAR
    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 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
    Last visit of last subject

    Substudy 1 will be completed before start of Substudy 2
    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 months
    E.8.9.1In the Member State concerned days
    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: 86
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 86
    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 state172
    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 expected normal treatment of that 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 Decision2020-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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