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    Summary
    EudraCT Number:2005-004712-73
    Sponsor's Protocol Code Number:P04351
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-15
    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 ConcernedGreece - EOF
    A.2EudraCT number2005-004712-73
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
    A.4.1Sponsor's protocol code numberP04351
    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 SponsorSchering-Plough Research Institute, a division of Schering Corporation
    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 nameNK 1 Receptor Antagonist - Rolapitant
    D.3.2Product code SCH 619734
    D.3.4Pharmaceutical form Capsule, hard
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5, 10, 50
    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 placeboCapsule, hard
    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
    Chemotherapy Induced Nausea and Vomiting
    MedDRA Classification
    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 that administration of SCH 619734 with ondansetron and dexamethasone improve CINV in the combined acute and delayed phase (0-120 hours), compared with the administration of placebo with ondansetron and dexamethasone alone in subjects receiving HEC.
    E.2.2Secondary objectives of the trial
    1. Determine the effect of SCH 619734 on complete response rate in the acute- (0 to 24 hrs) and delayed (> 24 to 120 hrs) phase of CINV.

    2. Determine the effect of SCH 619734 treatment on the incidence of no emesis, no nausea, no significant nausea, total control, and complete protection in the acute, delayed, & combined phase of CINV, as well as determine time to emesis or to rescue medication.

    3. Evaluate the effect of SCH 619734 treatment on quality of life, as assessed by the Functional Living Index Emesis Questionnaire (FLIE).

    The secondary safety objective of this study is to determine if SCH 619734 is safe and well-tolerated in patients receiving HEC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is equal to or older than 18 years of age.

    2. Subject has never been treated with cisplatin in the past and is to receive first course of cisplatin-based chemotherapy (≥70 mg/m2).

    3. Subject has a Karnofsky performance score of greater than or equal to 60.

    4. Subject has a predicted life expectancy of greater than or equal to 3 months.

    5. Subject has adequate bone marrow, kidney and liver functions, as evidenced by.
    a. Absolute neutrophil count greater than or equal to 1,500/mm3 and WBC count greater than or equal to 3,000/mm3.
    b. Platelet count greater than or equal to 100,000/mm3.
    c. AST less than or equal to 2.5 x upper limit of normal range.
    d. ALT less than or equal to 2.5 x upper limit of normal range.
    e. Bilirubin less than or equal to 1.5 x upper limit of normal range, except for subjects with Gilbert syndrome.
    f. Creatinine less than or equal to 1.5 x upper limit of normal range.

    If a single or multiple laboratory test value exceeds, but is close to, the limit(s) of the reference range(s) as defined in the protocol, subjects will be allowed to repeat these out –of-range tests once. If the repeated test results meet the study requirement, these subjects can be enrolled.

    6. Female subjects of childbearing potential must agree to use a physical method of contraception. Female subjects who are postmenopausal (ie, have amenorrhea for 12 months) or surgically sterile are exempted from the use of contraception during the study.

    7. Subject is able to read, understand, and complete the FLIE Questionnaire, SPNVHSU Scale, SPNVWAPI Questionnaire, SPNV Subject Diary, SPNVQOL Scale, and other study-related documents.

    8. Subject provides written informed consent.
    E.4Principal exclusion criteria
    1. Any current treatment or medical history (eg, subject is mentally incapacitated, has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.

    2. Subject has a contraindication to the administration of cisplatin, ondansetron, or dexamethasone, including but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.

    3. Subject is a woman of childbearing potential with a positive urine pregnancy test 3 days prior to study drug administration.

    4. Subject has previously received cisplatin.

    5. Subject has participated in a clinical trial receiving the last dose of the investigational agent within 30 days prior to the start of administration of study drug.

    6. Subject has taken the following agents within the last 5 days prior to the start of treatment with study drug until Day 6 of the study unless these agents are used as rescue medication or as part of the study treatment:
    a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc)
    b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc)
    c. Antipsychotics (haloperidol, droperidol, olanzepin, etc)
    d. Benzamides (metoclopramide, alizapride, etc)
    e. Domperidone
    f. Cannabinoids
    g. NK1 antagonist (aprepitant)
    h. benzodiazepines
    i. Antihistamines (dimenhyinate, diphenylhyramine, etc)
    j. Excessive alcohol consumption (ie, more than two drinks per day)

    7. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh scale) from Day 2 through Day 6. There is no restriction for Day 1.

    8. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.

    9. Subject has received systemic corticosteroid therapy within 72 hours of Day 1 of the study, except as premedication for chemotherapy. The subjects who are receiving chronic daily steroid therapy can be enrolled provided that the daily steroid dose is less than or equal to 10 mg of prednisone or equivalent.

    10. Subject who has symptomatic primary or metastatic CNS malignancy.

    11. Subject who has ongoing vomiting caused by any organic etiology or has a history of anticipatory nausea and vomiting.

    12. Subject who is planning to receive chemotherapy on multiple days with cisplatin in a single cycle.

    13. Subject who has vomited and/or has dry heaves/retching within 24 hours prior to the start of cisplatin infusion on Day 1 in Cycle 1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is the overall complete response rate (no emesis and no use of rescue medication 0 through 120 hours following initiation of cisplatin-based chemotherapy).

    The key secondary endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV. Other secondary endpoints for this study include
    - No emesis (no vomiting, retching, or dry heaves; includes subjects who received rescue medication): overall, acute, and delayed phases of CINV.
    - No nausea (maximum visual analog score (VAS) <5 mm): overall, acute, and delayed phases of CINV.
    - No significant nausea (maximum VAS <25 mm): overall, acute, and delayed phases of CINV
    -Time to first emesis or to rescue medication.
    - Total control (no emesis, no rescue medication, and maximum nausea VAS <5 mm on a 0- to 100-mm scale): overall, acute, and delayed phases CINV.
    - Complete protection (no emesis, no rescue medication, and maximum nausea VAS <25 mm on a 0- to 100-mm scale): overall, acute, and delayed phases of CINV.
    - Impact of CINV on daily life assessed by the FLIE Questionnaire
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 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.8.5The trial involves multiple Member States Yes
    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 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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 Information not present in EudraCT
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 450
    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)
    Not applicable
    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 Decision2007-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-27
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