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    Summary
    EudraCT Number:2008-007827-14
    Sponsor's Protocol Code Number:PALO-08-09
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-08-20
    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 number2008-007827-14
    A.3Full title of the trial
    Multicenter, Phase IV, Open-Label, Uncontrolled Study to Assess the Efficacy and Safety of a Single Intravenous Dose of Palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Non-Hodgkin’s Lymphomas Undergoing Repeated Cycles of Moderately Emetogenic Chemotherapy
    A.4.1Sponsor's protocol code numberPALO-08-09
    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
    D.2.1.1.2Name of the Marketing Authorisation holderHelsinn Birex Pharmaceuticals 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 namePalonosetron hydrochloride
    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 INNAloxi
    D.3.9.1CAS number 135729-61-2
    D.3.9.3Other descriptive namePALONOSETRON HYDROCHLORIDE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of moderately emetogenic CINV in up to four repeated and consecutive single-day MEC cycles administered to patients with Non-Hodgkin’s Lymphomas.
    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
    The main objective is to assess the efficacy of single doses of intravenous (IV) palonosetron 0.25 mg (Aloxi®, Onicit®, Paloxi®) in individual study cycles and the maintenance of such efficacy through repeated and consecutive study cycles, when administered for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) to patients with Non Hodgkin’s Lymphomas receiving repeated (a minimum of two up to a maximum of four) and consecutive single-day moderately emetogenic chemotherapy (MEC) cycles.
    E.2.2Secondary objectives of the trial
    A further objective is to evaluate the safety of IV palonosetron in initial and repeated consecutive MEC cycles for up to four study cycles.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be included in this study, or to continue participating in any of the repeated study cycles, the patients must meet the following criteria:
    1. Male or female ≥18 years of age
    2. Histologically or cytologically confirmed Non-Hodgkin’s Lymphoma
    3. Patient scheduled to receive single-day MEC as one of the following regimens (at each study cycle) in at least two repeated and consecutive chemotherapy cycles:
    • CHOP or R-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone, with or without Rituximab)
    • ProMACE-CytaBOM (cyclophosphamide, doxorubicin, etoposide, cytarabine, bleomycin, vincristine, methotrexate, leucovorin and prednisone)
    Note: Consecutive chemotherapeutic cycles must employ the same chemotherapeutic regimen. This can include changes in dose (adjustments of dose) of the MEC agent(s) or discontinuation of low, minimal or non-emetogenic concomitant chemotherapeutic agents as clinically appropriate, with no highly emetogenic agents added. For more details refer to Section 7.7.2 of protocol.
    4. Naïve to cancer chemotherapy (i.e. the patient has no chemotherapeutic history)
    5. A Karnofsky Performance Status of ≥ 50%, at each study cycle
    6. Signed written informed consent (with additional legal representative’s consent or parent’s consent if required)
    7. Patient with a known hepatic, renal or cardiovascular impairment, including cardiac conduction interval abnormalities, and scheduled to receive the above mentioned chemotherapeutic agents, may be enrolled in this study or continue the participation in each of the repeated study cycles at the discretion of the Investigator
    8. Female patient of childbearing potential must be using reliable contraceptive measures with a negative urine pregnancy test before any study treatment administration.
    E.4Principal exclusion criteria
    Patients are excluded from the enrollment in this study or from the participation in any of the subsequent repeated study cycles if they meet any of the following criteria:
    1. Inability to understand or co-operate with the study procedures, at any study cycle
    2. Any investigational drugs (other than those given in this study) administered within 30 days before intake of study medication, at each study cycle
    3. Any drug with potential anti-emetic efficacy administered within 24 hours of the intake of study medication, at each study cycle. Examples of these drugs are listed in the protocol Appendix E. Patients taking topical or inhaled steroids may be enrolled in the study
    4. Any vomiting, retching, or NCI Common Toxicity Criteria Grade 2 or 3 nausea in the 24 hours preceding chemotherapy, at each study cycle
    5. Treatment with commercial palonosetron (Aloxi®, Onicit® and Paloxi®) within 2 weeks prior to the intake of study treatment, at each study cycle
    6. Enrollment in a previous study with palonosetron
    7. Ongoing vomiting from any organic etiology, at each study cycle
    8. Presence of a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication (prophylactic anticonvulsant medication for patients free of seizure activity is allowed), at each study cycle
    9. IV Palonosetron 0.25 mg not administered in consecutive MEC cycles (see Section 7.1)
    10. Patient with AIDS-related B-cell Lymphoma
    11. Patient testing positive to the HBsAg test at the Screening Visit.
    12. Scheduled to receive:
    • Moderately emetogenic chemotherapy between the Screening Visit and the first study medication administration, on Days 2 to 5 of each study cycle, or on any day between two consecutive study cycles
    • Highly emetogenic chemotherapy, orally or intravenously: any dose of cisplatin, dacarbazine, streptozotocin, carmustine, mechlorethamine, hexamethylmelamine or procarbazine; or cyclophosphamide ≥1500 mg/m2 between the Screening Visit and the first study medication administration or during the study
    • Radiotherapy of upper abdomen or cranium or total body irradiation within 7 days prior to the first study medication administration or during the study
    • Any low-level emetogenic chemotherapeutic agent during Days 2 to 5 of each study cycle, if this chemotherapy, in the Investigators’ opinion, requires co-administration of additional anti-emetics. Administration of low-level emetogenic chemotherapy without additional anti-emetics is allowed on Days 2 to 5
    13. Known contraindication to 5-HT3 receptor antagonists, at each study cycle.
    E.5 End points
    E.5.1Primary end point(s)
    The main efficacy parameter in this study is the proportion of patients considered to have achieved a CR (defined as no emetic episode and no rescue medication) during the first 120 hours after administration of chemotherapy (overall 0 to 120 hour interval). The proportion of patients achieving CR for the 0 to 120 hour interval (and exact 95% confidence interval) will be summarized for each study cycle for the IV palonosetron 0.25 mg dose. Other efficacy parameters are the proportion of patients considered to have achieved a CR during the 0 to 24 hour and during the 24 to 120 hour intervals after administration of chemotherapy. The proportion of complete responders (and exact 95% confidence interval) in these time periods will be summarized for each study cycle for the IV palonosetron 0.25 mg dose.
    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 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 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 EEA20
    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
    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 months4
    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 months4
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 200
    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 the end of the trial, the Investigator may continue administering commercial palonosetron 0.25 mg IV (Aloxi®, Onicit®, Paloxi®), in line with local prescribing information, to study patients requiring additional chemotherapy cycles after completing the present study on the basis that palonosetron IV (Aloxi®, Onicit®, Paloxi®) is currently marketed.
    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 Decision2009-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-04-30
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