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    Summary
    EudraCT Number:2009-014691-21
    Sponsor's Protocol Code Number:GAND-emesis
    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:2011-12-06
    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 number2009-014691-21
    A.3Full title of the trial
    GAND-emesis
    A multinational, randomized, double-blind,
    placebo-controlled, parallel-group study
    to investigate the efficacy and tolerability of
    palonosetron and dexamethasone plus the neurokinin1-receptor antagonist, fosaprepitant dimeglumine or placebo in patients receiving radiotherapy and concomitant weekly cisplatin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study that investigates the effect of Fosaprepitant in combination with two other anti-emetics (Palonosetron and Dexamethasone) in patients with cervical cancer who receive a combined therapy of radiotherapy and chemotherapy with cisplatin
    A.3.2Name or abbreviated title of the trial where available
    GAND-emesis
    A.4.1Sponsor's protocol code numberGAND-emesis
    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 supportOdense 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 pointJorn Herrstedt
    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 number+4565413634
    B.5.6E-mailherrstedt@ouh.regionsyddanmark.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Ivemend
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd.
    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.3.1Product nameIvemend
    D.3.4Pharmaceutical form Powder 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.3.9.1CAS number 265121048
    D.3.9.3Other descriptive nameFOSAPREPITANT MEGLUMINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Aloxi
    D.2.1.1.2Name of the Marketing Authorisation holderRiemser Pharma
    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.3.1Product namePalonosetron
    D.3.2Product code n.a.
    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 INNPALONOSETRON
    D.3.9.1CAS number 135729-56-5
    D.3.9.3Other descriptive nameAloxi
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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: 3
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderGalenPharma
    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.3.1Product nameDexamethasone
    D.3.2Product code n.a.
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethason
    D.3.9.1CAS number 50-02-2
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive nameDEXAMETHASONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    cervical cancer
    E.1.1.1Medical condition in easily understood language
    Cervical cancer is malignant neoplasm of the cervix uteri or cervical area.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10036902
    E.1.2Term Prophylaxis against radiation induced nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 is to compare an antiemetic regimen consisting of fosaprepitant dimeglumine (Ivemend®), palonosetron (Aloxi®), and dexamethasone (active arm) and a regimen consisting of palonosetron, dexamethasone, and placebo (control arm) with respect to efficacy; the proportion of subjects with no vomiting, i.e. sustained no emesis rate - during five weeks of fractionated (5 days a week) radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.</
    E.2.2Secondary objectives of the trial
    1. To compare the fosaprepitant regimen and the control regimen in terms of the proportion of subjects with complete response in the 7 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2. 2. To compare the fosaprepitant regimen and the control regimen in terms of the proportion of subjects with no significant nausea during five weeks (35 days) (of treatment as above) 3. To compare the fosaprepitant regimen and the control regimen with respect to complete response in the 35 days following initiation of treatment as above. 4. To compare the fosaprepitant regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) (of treatment as above). 5. To compare the fosaprepitant regimen and the control regimen in terms of the number of days to first emetic episode. 6. To compare quality of life using the FLIE questionnaire. 7. To compare tolerability of both regimens.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has a diagnosis of cervical cancer. 2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent. 3. The patient is aged > 18 years. 4. The patient must be both chemo- and radiotherapy naïve. 5. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks, and planned brachy therapy should preferentially be scheduled after the fifth week of treatment. 6. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 17). 7. The patient has a WHO Performance Status of ≤ 2. 8. Hematologic and metabolic status must be adequate for receiving weekly cisplatin in a dose of ≥ 40 mg/m2, and meet the following criteria: • Total neutrophils ≥ 1500/mm3 (Standard units : ≥1.5 x 109/L) • Platelets ≥ 100,000/mm3 (Standard units: ≥100.0 x 109/L) • Bilirubin ≤ 1.5 x ULN (Upper Limits of Normal) • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x ULN • GFR ≥ 50 ml/min 9. The patient is able to read, understand, and complete questionnaires and daily components of the Patient Diary for each study cycle. 10. For patients of childbearing potential, urine human chorionic gonadotropin (hCG) (urine dipstick pregnancy test) results must be negative at screening, and these patients must agree to one of the following methods of contraception: • Male partner who is sterile prior to the patient’s entry into the study and is the sole sexual partner for that patient. • Double-barrier method of contraception consisting of spermicide with either condom or diaphragm. • Complete abstinence from intercourse for two weeks before study entry and throughout the study period plus a period after the trial to account for elimination of the drug (minimum of eight days). Oral contraceptives (e.g., oral, injectable, trans dermal, or implantable) are NOT considered safe because of potential lowered ethinyloestradiol exposures when co-administered with fosaprepitant and dexamethasone (see Appendix 1, p230).</
    E.4Principal exclusion criteria
    1. The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers. 2. The patient is aged ≤ 18 years. 3. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin. 4. The patient has been previously treated with radiotherapy, and/or chemotherapy. 5. The patient has a WHO Performance Status of > 2. 6. Hematologic and metabolic status are inadequate, i.e. • Total neutrophils < 1500/mm3 (Standard units : ≥1.5 x 109/L) • Platelets < 100,000/mm3 (Standard units: ≥100.0 x 109/L) • Bilirubin > 1.5 x ULN • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x ULN • GFR ≤ 50 ml/min 7. The patient is unable to read, understand, and complete the forms required for the study. 8. The patient is pregnant or lactating. 9. The patient with a reproductive potential refuses to use adequate contraception. 10. The patient has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea in the 24 hours preceding the first dose of study medication. 11. The patient has a history active peptic ulcer disease, gastrointestinal obstruction, gastrointestinal carcinoma, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV/RINV) or pose an unwarranted risk to the patient. 12. The patient has a known hypersensitivity or contraindication to palonosetron, another 5-HT3 receptor antagonist, dexamethasone, or any component of fosaprepitant. 13. The patient has previously received an NK1 receptor antagonist. 14. The patient has received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug other than the study medication during the study period. 15. The patient has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medications. Opiate drugs for cancer pain will be permitted if the patient has been on a stable dose and has not experienced emesis or clinically significant nausea from the narcotics in the 24 hours preceding the first dose of study medication. 16. The patient has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drugs. This includes, but is not limited to: • 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonosetron is not permitted within 7 days prior to receiving study drugs. • Benzamide / benzamide derivatives (e.g., metoclopramide, alizapride). • Benzodiazepines (except if the patient is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to the first dose of casopitant investigational product and study medications). • Phenothiazines (e.g., prochlorperazine, promethazine, metopimazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine). • Butyrophenone (e.g., haloperidol, droperidol). • Corticosteroids (e.g., dexamethasone, methylprednisolone, prednisolone; with the exception of topical steroids for skin disorders, inhaled steroids for respiratory disorders). • Anticholinergics (e.g., scopolamine). • Antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine). • Domperidone. • Cannabinoids. • Mirtazapine. • Olanzapine. 17. Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 prior to administration of study drugs (see Section 10.3.1., “Inhibitors of CYP3A4 and CYP3A5”). 18. Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of study drugs (see Section 10.3.2., “Inducers of CYP3A4 and CYP3A5”). 19. Is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of fosaprepitant is a potential inhibitor of CYP2C8 (See Section 10.3.4., “Exclusion and Necessary Caution with CYP2C8 Substrates”).</
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 'sustained no emesis rate' during five weeks of fractionated (5 days a week) radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2. Sustained no emesis during five weeks means that the study subject is free from vomiting episodes in the interval beginning at infusion of first dose of cisplatin untill 7 days after the infusion of the fifth dose of cisplatin.</
    E.5.1.1Timepoint(s) of evaluation of this end point
    every weeks for 5 weeks
    E.5.2Secondary end point(s)
    1. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with complete response (defined as no vomits, no dry retches and no need for rescue medication) in the 7 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
    2. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no significant nausea (none or mild nausea) during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
    3. To compare the fosaprepitant dimeglumine regimen and the control regimen with respect to complete response (defined as no vomits, no dry retches and no need for rescue medication) in the 35 days following initiation of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
    4. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the proportion of subjects with no nausea during five weeks (35 days) of fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2.
    5. To compare the fosaprepitant dimeglumine regimen and the control regimen in terms of the number of days to first emetic episode.
    6. To compare quality of life using the FLIE questionnaire.
    7. To compare tolerability of both regimens.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every weeks for 5 weeks
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    quality of life
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Australia
    Denmark
    Norway
    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
    Study will be closed when all 230 patients are enroled, and the last patient has completed the follow-up visit.<
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 230
    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 study participation subjects will receive an antiemetic regimen left to the descretion of the investigator or site staff at that specific site.
    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 Decision2011-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-04-24
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