Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-022743-37
    Sponsor's Protocol Code Number:TS-P04833
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-13
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2010-022743-37
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Double-Blind, Active-Controlled Study of the Safety and Efficacy of Rolapitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study of Rolapitant versus Placebo for the prevention of nausea and vomiting related to chemotherapy that has a high likelihood of inducing nausea and vomiting.
    A.4.1Sponsor's protocol code numberTS-P04833
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01500213
    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 SponsorTesaro, 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 supportTesaro, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (UK) Ltd, Representative office Belgrade
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressOmladinskih brigada 88b
    B.5.3.2Town/ cityBelgrade
    B.5.3.3Post code11070
    B.5.3.4CountrySerbia
    B.5.4Telephone number+38 111 3538 715
    B.5.5Fax number+38 111 353 87 50
    B.5.6E-mailJovana.Vujanovic@pharm-olam.com
    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 nameRolapitant
    D.3.2Product code SCH 619734 hydrochloride monohydrate
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNRolapitant
    D.3.9.1CAS number 914462-92-3
    D.3.9.2Current sponsor codeSCH 619734 hydrochloride monohydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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 (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
    E.1.1.1Medical condition in easily understood language
    Nausea and Vomiting in Subjects Receiving Highly Emetogenic Chemotherapy
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10049091
    E.1.2Term Chemotherapy antiemetic prophylaxis
    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 determine whether administration of rolapitant with granisetron and dexamethasone improves CINV in the delayed phase (>24 to 120 hours) of CINV compared with administration of placebo with granisetron and dexamethasone in subjects receiving HEC. The primary outcome will be based on complete response (defined as no emetic episodes and no rescue medication) in the delayed phase (>24 to 120 hours).
    E.2.2Secondary objectives of the trial
    - To determine the effect of rolapitant on complete response rates in the acute (0 to 24 hours) and overall (0 to 120 hours) phases of CINV.
    - To determine if rolapitant is safe and well tolerated in subjects receiving HEC.
    - To determine the effect of rolapitant treatment on the incidences of no emesis in the acute, delayed and overall phases of CINV.
    - To determine the effect of rolapitant treatment on the incidence of no significant nausea in the overall phase of CINV.
    - To determine the effect of rolapitant treatment on the time to first emesis or use of rescue medication.
    Pharmacokinetic Objective:
    - To evaluate the population pharmacokinetics of rolapitant and its primary metabolite in patients receiving highly emetogenic chemotherapy.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is 18 years of age or older, of either gender, and of any race.
    2. Subject has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2).
    3. Subject has a Karnofsky performance score of ≥60.
    4. Subject has a predicted life expectancy of ≥4 months.
    5. Subject has adequate bone marrow, kidney, and liver function as evidenced by:
    a. Absolute neutrophil count ≥1500/mm3.
    b. Platelet count ≥100,000/mm3.
    c. Aspartate aminotransferase (AST) ≤2.5 x upper limit of normal range (ULN). For subjects with known liver metastases ≤5 x ULN.
    d. Alanine aminotransferase (ALT) ≤2.5 x ULN. For subjects with known liver metastases ≤5 x ULN.
    e. Bilirubin ≤1.5 x ULN, except for subjects with Gilbert‘s syndrome.
    f. Creatinine ≤1.5 x ULN.
    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 inclusion criteria, 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 medically accepted method of birth control prior to Visit 1 and to continue its use during the study and for at least 30 days after the study. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, hormonal contraception, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), and surgical sterilization (e.g., vasectomy, hysterectomy, or tubal ligation). Female subjects who are postmenopausal (i.e., 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 all study-related documents.
    8. Subject provides written informed consent.
    E.4Principal exclusion criteria
    1. Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) 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, granisetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, or systemic infection.
    3. Subject is a woman of childbearing potential with a positive urine or serum pregnancy test within 3 days prior to study drug administration or is breast feeding.
    4. Subject has previously received cisplatin or subject is planning to receive multiple days of cisplatin in a single cycle.
    5. Subject has taken the following agents within the last 48 hours prior to the start of treatment with study drug.
    a. 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.). Palonosetron is not permitted within 7 days prior to administration of investigational product.
    b. Phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.).
    c. Benzamides (metoclopramide, alizapride, etc.).
    d. Domperidone.
    e. Cannabinoids.
    f. NK1 antagonist (aprepitant).
    g. Benzodiazepines (lorazepam, alprazolam, etc.).
    6. Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 4 or above (Hesketh Scale) from Day -2 through Day 6, except on Day 1. (There is no restriction for Day 1.)
    7. Subject is scheduled to receive any radiation therapy to the abdomen or pelvis from Day -5 through Day 6.
    8. Subject has received systemic corticosteroids or sedative antihistamines (dimenhydrinate, diphenhydramine, etc.) within 72 hours of Day 1 of the study except as premedication for chemotherapy (e.g., taxanes, pemetrexed). Subjects who are receiving inhaled steroids for respiratory conditions or topical steroids for skin disorders can be enrolled.
    9. Subject has symptomatic primary or metastatic CNS disease.
    10. Subject has ongoing vomiting, retching, clinically significant nausea caused by any etiology, or has a history of anticipatory nausea and vomiting.
    11. Subject has vomited and/or has had dry heaves/retching within 24 hours prior to the start of cisplatin-based chemotherapy on Day 1 in Cycle 1.
    12. Subject who has used any investigational drugs within 30 days of randomization.
    13. Subject who is participating in any other clinical study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for this study is the complete response rate in the delayed phase of CINV, from >24 through 120 hours following initiation of cisplatin-based chemotherapy. Complete response is defined as no emetic episodes and no use of rescue medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    No emesis and no rescue medication taken >24 through 120 hours following initiation of cisplatin-based chemotherapy
    E.5.2Secondary end point(s)
    The key secondary endpoints are the complete response rates for the acute (0 through 24 hours) and overall (0 through 120 hours) phases of CINV.
    The following additional secondary efficacy endpoints will be assessed:
    - No emesis (no vomiting, retching, or dry heaves; includes subjects who received rescue medication) during the acute, delayed and overall phases of CINV
    - No significant nausea (maximum VAS <25 mm) during the overall phase of CINV
    - Time to first emesis or to rescue medication.
    Pharmacokinetic Endpoint:
    - Population PK parameter estimates of rolapitant and its active metabolite, SCH 720881.
    -Time to first vomiting episode.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cycle 1:
    - Overall: 0 to 120 hours following initiation of cisplatin-based chemotherapy.
    - Acute: 0 to 24 hours following initiation of cisplatin-based chemotherapy.
    - Delayed: >24 to 120 hours following initiation of cisplatin-based chemotherapy.
    For Cycle 1, a TC will be made with each subject on Days 2 to 5 and on Days 6, 7, or 8 in each subsequent cycle (Cycles 2 to 6) with exception of Day 4 for sites involved in PK assessments) at approximately the same time each day to assess the subject‘s status and to ensure that the subject is appropriately recording any vomiting episodes, use of rescue medication, and daily nausea ratings in the NV Subject Diary.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Brazil
    Czech Republic
    Ecuador
    Georgia
    Hungary
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    South Africa
    Spain
    Taiwan
    Ukraine
    United States
    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
    The overall study ends when the last remaining subject has completed or has been discontinued from the study.The subject is considered to have completed the study upon the completion of the last protocol-specified contact at Cycle 6, or at the final chemotherapy cycle he/she elects to participate. The last protocol-specified contact should be performed either by visit or phone approximately 30 days after the last administration of the study drug.
    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 months2
    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 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.1.2.1Number of subjects for this age range: 424
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 106
    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 152
    F.4.2.2In the whole clinical trial 530
    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)
    Standard medical care
    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 Decision2012-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-24
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 13:40:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA