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    The EU Clinical Trials Register currently displays   43866   clinical trials with a EudraCT protocol, of which   7287   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005068-29
    Sponsor's Protocol Code Number:C2006-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-24
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-005068-29
    A.3Full title of the trial
    A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi® for the Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following the Administration of either Moderately or Highly Emetogenic Chemotherapy Regimens
    A.4.1Sponsor's protocol code numberC2006-01
    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 SponsorA.P. Pharma, Inc.
    B.1.3.4CountryUnited States
    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 No
    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 nameAPF530
    D.3.2Product code 2% granisetron TEG-POE Polymer formulation
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGRANISETRON
    D.3.9.1CAS number 109889090
    D.3.9.2Current sponsor codeAPF530
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) 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 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 No
    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 nameAPF530
    D.3.2Product code 2% granisetron TEG-POE Polymer formulation
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGRANISETRON
    D.3.9.1CAS number 109889090
    D.3.9.2Current sponsor codeAPF530
    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) 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: 3
    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
    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.3.4Pharmaceutical 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 135729565
    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) 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
    Chemotherapy Induced Nausea and Vomiting
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10054133
    E.1.2Term Prophylaxis of nausea and vomiting
    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 objectives of the study are to evaluate in the first qualifying chemotherapy treatment the efficacy of a single dose of a sustained release formulation of granisetron (APF530) in comparison to Aloxi® for the prevention of acute-onset and delayed-onset CINV in subjects currently undergoing moderately or highly emetogenic chemotherapy:
    1. To test the non-inferiority of APF530 for the prevention of acute-onset CINV following administration of either moderately emetogenic or highly emetogenic chemotherapy in comparison to Aloxi®.
    2. To test the non-inferior efficacy of APF530 for the prevention of delayed-onset CINV following administration of moderately emetogenic chemotherapy in comparison to Aloxi®.
    3. To test the superior efficacy of APF530 for the prevention of delayed-onset CINV following administration of highly emetogenic chemotherapy in comparison to Aloxi®
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the safety and tolerability, sustained efficacy, and pharmacokinetics of APF530 in subjects undergoing moderately or highly emetogenic chemotherapy over multiple qualifying chemotherapy treatments:
    1. To evaluate the safety and tolerability of APF530 for the prevention of acute-onset and delayed-onset CINV following administration of the first and subsequent chemotherapy treatments.
    2. To evaluate the efficacy of APF530 for the prevention of acute-onset and delayed-onset CINV during multiple chemotherapy treatments.
    3. To gather pharmacokinetic APF530 data in a subset of subjects undergoing moderately or highly emetogenic chemotherapy during the first study drug treatment. This substudy is not being conducted in Poland (or the Community) per Protocol Addendum #1 dated 2007/08/08.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis and main criteria for inclusion and exclusion:
    Subject Population: Male or female subjects ≥ 18 years of age, with histologically or cytologically confirmed malignant disease, and scheduled to receive single-day administrations of moderately or highly emetogenic chemotherapy (determined using the Hesketh algorithm). Administration of chemotherapy should not extend beyond 4 hours excluding administration of monoclonal antibodies. Chemotherapy administrations must be separated by at least 7 days but should not be more than 28(+3) days apart. Study drug administrations cannot be more than 28(+ 3) days apart.

    Inclusion: Men and women 18 years of age or older who are scheduled to receive moderately emetogenic (Hesketh Level 3 and 4) or highly emetogenic (Hesketh Level 5) chemotherapy; have histologically or cytologically confirmed malignant disease; are able to receive the standardized doses of dexamethasone, as required by this protocol; have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; are willing and able to comply with all testing and requirements defined in this protocol; are willing and able to provide voluntary, written, informed consent to participate in this study, and the ability to fully understand the study requirements. Eligible patients are not required to be chemotherapy naïve. Female subjects cannot be pregnant and must be adequately protected from conception for the duration of study. It is recommended that females and female partners of male subjects remain adequately protected from conception for up to one year following study participation.
    E.4Principal exclusion criteria
    Exclusion: Treatment with chemotherapeutic regimens which are mildly or unlikely to be emetogenic (Hesketh Level 1 and 2); allergy or hypersensitivity to 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists or to local anesthetics; ECOG performance status of 3, 4 or 5; head and neck cancers that have compromised the brain vomiting and nausea centers, primary brain tumors and active/symptomatic brain metastases, or GI cancers with gastric or intestinal obstruction that may result in symptoms of nausea and vomiting; a psychological problem that, in the investigator’s opinion, is severe enough to preclude reliable study participation; recent history (within 1 year) of alcohol or drug abuse; greater than mild nausea or any vomiting within 24 hours prior to study drug administration; pregnancy (confirmed by serum or urine test) or breastfeeding; any concomitant condition that, in the opinion of the investigator, could affect assessment of the study drug or could interfere with the nausea/vomiting response, including severe renal or hepatic impairment; use of investigational drug within 30 days before study entry; subjects with QTc interval > 500 msec or with a cardiac abnormality predisposing the subject to arrhythmia.
    E.5 End points
    E.5.1Primary end point(s)
    The following efficacy measures will be evaluated daily during the first 5 days after administration of chemotherapy:

    Complete Response (CR): No emetic episodes and no use of rescue medication.
    Complete Control (CC): Complete response with no more than mild nausea.
    Total Response (TR): No nausea, no emetic episodes, and no use of rescue medications.

    For the purposes of this trial, an emetic episode is a single vomit or retch or any number of continuous vomits or retches. Continuous vomits or retches are defined as two or more vomits or retches with a gap of less than one minute between the individual vomits or retches.

    Diaries will be distributed to subjects to record emetic episodes, use of rescue medication, and severity of nausea experienced on a daily basis up to 120 hours following their chemotherapy, in up to 4 treatment cycles.

    Primary Endpoints

    Proportion of subjects with:
    1. CR during the acute phase (0 to 24 hours) following the administration of chemotherapy in Treatment Cycle 1.
    2. CR during the delayed-onset phase (24 to 120 hours) following the administration of chemotherapy in Treatment Cycle 1. CR will be measured in 24-hour increments up to 120 hours.
    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 Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    0.9% Sodium Chloride used in the study is for double dummy purposes to properly maintain the blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned10
    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 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
    Provided in the protocol.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months7
    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 months6
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 1338
    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)
    Treatment of subjects will be according to standard care when his/her particpation has ended in the trial.
    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 Decision2008-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-19
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