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    Summary
    EudraCT Number:2015-002294-38
    Sponsor's Protocol Code Number:DANSAC-open
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-26
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002294-38
    A.3Full title of the trial
    DANSAC-open: A multicenter, open label study to investigate the efficacy and tolerability of olanzapine in patients with advanced cancer not receiving chemotherapy or irradiation.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DANSAC-open: A multicenter, open label study to investigate the efficacy and tolerability of olanzapine in patients with advanced cancer not receiving chemotherapy or irradiation.
    A.3.2Name or abbreviated title of the trial where available
    DANSAC-open: DANish Study on Advanced Cancer - Open study
    A.4.1Sponsor's protocol code numberDANSAC-open
    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 SponsorOdense University Hospital
    B.1.3.4CountryDenmark
    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 supportThe Danish Cancer Society
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportOdense University Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDepartment of Oncology, Odense University Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOdense University Hospital
    B.5.2Functional name of contact pointSigne Harder
    B.5.3 Address:
    B.5.3.1Street AddressSdr Boulevard 29
    B.5.3.2Town/ cityOdense C
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number4525382590
    B.5.6E-mailsigne.harder@rsyd.dk
    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 Zalasta 10 mg orodispersible tablets
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Orodispersible tablet
    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 INNOLANZAPINE
    D.3.9.1CAS number 132539-06-1
    D.3.9.4EV Substance CodeSUB09426MIG
    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.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 ZYPREXA 10 mg powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOLANZAPINE
    D.3.9.1CAS number 132539-06-1
    D.3.9.4EV Substance CodeSUB09426MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Nausea and/or vomiting
    E.1.1.1Medical condition in easily understood language
    Nausea and/or vomiting
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10014542
    E.1.2Term Emesis
    E.1.2System Organ Class 100000017043
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Objectives: The primary objective is to test if olanzapine 10 mg is effective in patients with advanced cancer not receiving chemotherapy or irradiation.
    Hypotheses: Administration of olanzapine will result in a change in nausea score from baseline to 24 hours later exceeding 30%. In patients included because of vomiting only (nausea score less than moderate), the primary parameter will be change in number of emetic episodes from baseline to 24 hours later.
    E.2.2Secondary objectives of the trial
    1. Two-item nausea score and CAT (computer adaptive testing)-score recorded on the ext. EORTC QLQ-C15-PAL at baseline, 24 hours and after 7 days.
    2. Number of emetic episodes (vomit/dry retch) in the first 24 hours after administration of study medication.
    3. Time to first emetic episode.
    4. Nausea score measured daily for 7 days following administration of study medication
    5. Number of emetic episodes measured daily for 7 days following the administration of study medication.
    6. Tolerability of olanzapine 10 mg for 5 consecutive days.
    7. Parameters indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life.
    8. Use of rescue anti-emetics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Advanced cancer
    2. Age ≥ 18 years
    3. One or both of the following:
    3.1. Nausea at least ‘moderate’ on the baseline diary
    3.2. At least 1 emetic episode within the last 24 hours (recorded on the baseline diary)
    4. Ability to read and understand the forms required for the study
    5. Life-expectancy more than 2 weeks
    E.4Principal exclusion criteria
    1. Contraindications for olanzapine including allergic reaction, phenylketonuria and diagnosed glaucoma
    2. Cardiovascular disease, other than hypertension
    3. Parkinson’s disease
    4. Dementia
    5. Epilepsy
    6. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MR scan of the cerebrum are needed before inclusion
    8. Radiologic confirmed ileus, or clinical suspicion evaluated by the study Investigator
    9. Cognitive impairment or language barrier that makes the patient unable to complete the questionnaires
    10. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days.
    11. Chemotherapy within the last 2 weeks
    12: Radiation therapy targeting the brain or abdomen within the last 2 weeks
    12. Pregnancy
    13. Reversible causes of nausea/vomiting: e.g. Hypercalcemia, uremia , newly commenced/changed opioid-therapy (within 7 days), other medication with emetic potential
    E.5 End points
    E.5.1Primary end point(s)
    1. Nauseascore
    2. Number of emetic episodes
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recorded at baseline and 24 hours following first dose
    E.5.2Secondary end point(s)
    1. Two-item nausea score and CAT (computer adaptive testing)-score.
    2. Number of emetic episodes (vomit/dry retch) in the first 24 hours after administration of study medication.
    3. Time to first emetic episode.
    4. Nausea score
    5. Number of emetic episodes.
    6. Tolerability of olanzapine 10 mg for 5 consecutive days.
    7. Parameters indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life.
    8. Use of rescue anti-emetics.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline and study day 2 + baseline and daily study day 1-7
    2. Baseline and study day 2
    3. Daily study day 1-7.
    4. Baseline and daily study day 1-7
    5. Baseling and study day1-7
    6: Baseline, study day 2 and 7.
    7: Baseline and study day 7
    8. Baseline + daily staudy day 1-7.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    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.8.3 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 concerned5
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state40
    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)
    None
    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 Decision2015-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-05
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