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    Summary
    EudraCT Number:2010-022223-29
    Sponsor's Protocol Code Number:PALO-10-01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-05-09
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-022223-29
    A.3Full title of the trial
    Single-dose, multicenter, randomized, double-blind, double-dummy, parallel group study to assess the efficacy and safety of oral palonosetron 0.50 mg compared to I.V. palonosetron 0.25 mg administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving highly emetogenic cisplatin-based chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberPALO-10-01
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorHelsinn Healthcare SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Aloxi 500 microgrammi
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNPalonosetron
    D.3.9.1CAS number 135729-62-3
    D.3.9.2Current sponsor code08-PALO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 ALOXI*1FL 250MCG 5ML
    D.2.1.1.2Name of the Marketing Authorisation holderITALFARMACO SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 135729-62-3
    D.3.9.2Current sponsor code08-PALO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboSolution for injection
    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 placeboCapsule, soft
    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
    Nausea and vomiting in cancer patients receiving highly emetogenic cisplatin-based chemotherapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10054133
    E.1.2Term Prophylaxis of nausea and vomiting
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the non-inferiority of single dose oral palonosetron 0.50 mg versus single dose I.V. palonosetron 0.25 mg in terms of percentage of patients with complete response during the acute phase (0-24 hours).
    E.2.2Secondary objectives of the trial
    1) To assess the efficacy of single dose oral palonosetron 0.50 mg versus single dose I.V. palonosetron 0.25 mg by the evaluation of further secondary efficacy variables during the acute phase (0-24 hours) and to describe the efficacy during the delayed (25-120 hours) and overall (0-120 hours) phases. 2) To evaluate the safety and tolerability of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg for the prevention of HEC induced nausea and vomiting.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed written informed consent; 2.Male or female patient greater or equal than 18 years of age; 3. Na�ve to cytotoxic chemotherapy. Previous biological or hormonal therapy is permitted; 4.Diagnosed with a malignant solid tumor and scheduled to receive first course of cytotoxic chemotherapy with cisplatin administered as a single I.V. dose of greater or equal than 70 mg/m2 over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents; 5.If scheduled to receive combination regimens, non-cisplatin agents of moderate to high emetogenic potential (see Appendix 3, Emetogenic Levels of Intravenous Antineoplastic Agents according to MASCC/ESMO guidelines) are allowed and they must be administered following the cisplatin infusion and completed no more than 6 hours after the initiation of cisplatin infusion; 6.If scheduled to receive chemotherapy agents of minimal to low emetogenic potential (Appendix 3), they are to be given on Day 1 following cisplatin or on any subsequent study day; 7.ECOG Performance Status of 0, 1, or 2 (Appendix 4); 8.Female patients of either: a.non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as 12 consecutive months of amenorrhea). In addition, postmenopausal definition has to be confirmed by consistent age and/or Follicle-Stimulating Hormone (FSH) levels), b.child-bearing potential with a negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product at Day 1 and with a commitment to consistent and correct use throughout the clinical trial of one of the following contraceptive methods: - whose male partner is sterile prior to the female patient’s entry into the study and is the sole sexual partner, - using double-barrier method of contraception consisting of spermicide with either condom or diaphragm, also if taking any oral contraceptive, for a period after the trial to account for a potential drug interaction (minimum four weeks), - with intrauterine device (IUD), - with complete abstinence from intercourse for two weeks before exposure to the investigational product and throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of fourteen days); should patients become sexually active during the period described above, they must agree to follow an acceptable method of birth control, as described above; 9.Hematologic and metabolic status adequate for receiving a highly emetogenic cisplatin-based regimen and fulfillment of the following criteria: a)Total Neutrophils greater or equal than 1500/mm3 (Standard units: greater or equal than 1.5 x 10^9/L) - b)Platelets greater or equal than 100,000/mm3 (Standard units: greater or equal than 100.0 x 10^9/L) - c)Bilirubin less or equal than 1.5 x Upper Limit of Normal (ULN) - d)Liver enzymes: Without known liver metastases, Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) less or equal than 2.5 x Upper Limit of Normal (ULN) - With known liver metastases, AST and/or ALT less or equal than 5.0 x Upper Limit of Normal (ULN) - e)Serum Creatinine less or equal than 1.5 mg/dL (Standard units: less or equal than 132.6 microMOL/L) or Creatinine Clearance greater or equal than 60 mL/min; 10.If a patient has a known hepatic or renal impairment, he/she may be enrolled in this study at the discretion of the Investigator (for the complete list please make reference to paragraph 3.3.1 of the protocol)
    E.4Principal exclusion criteria
    1.If female, pregnant or lactating; 2.Current use of illicit drugs or current evidence of alcohol abuse; 3.Scheduled to receive moderately emetogenic chemotherapy (MEC) or HEC (Appendix 3) from Day 2 to Day 5 following cisplatin administration; 4.Received or is scheduled to receive radiation therapy to the abdomen, or the pelvis within 1 week prior to Day 1 or between Days 1 to 5; 5.Any vomiting, retching, or mild nausea (grade greater or equal than I as defined by National Cancer Institute) within 24 hours prior to Day 1; 6. Symptomatic primary or metastatic CNS malignancy; 7.Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical conditions (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient; 8.Known hypersensitivity or contraindication to 5-HT3 receptor antagonists (e.g., palonosetron, ondansetron, granisetron, dolasetron, tropisetron, ramosetron) or dexamethasone; 9.Participation in a clinical trial involving palonosetron; 10.Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the study. 11.Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1. However topical and inhaled corticosteroids with a steroid dose of less or equal than 10 mg of prednisone daily or its equivalent are permitted; 12.Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy; 13.Any medication with known or potential antiemetic activity within 24 hours prior to Day 1, including: - 5‑HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron, palonosetron), - NK-1 receptor antagonists (e.g., aprepitant or any other new drug of this class), - benzamides (e.g., metoclopramide, alizapride), - phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine), - benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to Day 1), - butyrophenones (e.g., haloperidol, droperidol), - anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide), - antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine, chlorphenhyramine), except for prophylactic use for taxane therapy domperidone, - mirtazapine, - olanzapine, - prescribed cannabinoides (e.g., tetrahydrocannabinol or nabilone); 14.Any illness or condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient; 15.Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients with Complete Response (CR) defined as no emesis, no rescue medication within 24 hours after the start of the HEC administration on Day 1
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    non inferiorita`
    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 No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Conclusione della sperimentazione: ultima visita dell`ultimo paziente (o ultimo contatto telefonico)
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.3Elderly (>=65 years) Yes
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 355
    F.4.2.2In the whole clinical trial 750
    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 Decision2011-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-30
    P. End of Trial
    P.End of Trial StatusCompleted
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