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    Summary
    EudraCT Number:2012-001751-38
    Sponsor's Protocol Code Number:2011_29
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-12-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-001751-38
    A.3Full title of the trial
    SECONDARY PROPHYLAXIS USE OF ROMIPLOSTIM FOR THE PREVENTION OF THROMBOCYTOPENIA IN NEWLY DIAGNOSED GLIOBLASTOMA PATIENTS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SECONDARY PROPHYLAXIS USE OF ROMIPLOSTIM FOR THE PREVENTION OF THROMBOCYTOPENIA IN NEWLY DIAGNOSED GLIOBLASTOMA PATIENTS
    A.3.2Name or abbreviated title of the trial where available
    PLATUM
    A.4.1Sponsor's protocol code number2011_29
    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 SponsorCHRU de Lille
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Lille
    B.5.2Functional name of contact pointY. MORICE
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Oscar Lambret
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    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 Nplate 250 micrograms powder for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameNplate 250 micrograms powder for solution for injection
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Thrombocytopenia induced by chemotherapy in glioblastomas.
    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 LLT
    E.1.2Classification code 10043559
    E.1.2Term Thrombocytopenia toxic
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10018336
    E.1.2Term Glioblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 the incidence of completed chemotherapy cycles
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of Romiplostim in treating Chemotherapy Induced Thrombocytopenia (CIT) in newly diagnosed glioblastoma patients receiving myelosuppressive chemotherapy by Temozolomide (TMZ).
    • To determine the incidence of delayed chemotherapy cycles and the incidence of chemotherapy cycles with dose reduction due to severe TP.
    • To describe the incidence of TP resolution during Romiplostim treatment period.
    • To determine the incidence of platelets transfusion for TP during Romiplostim treatment.
    • To describe the adverse events during Romiplostim and Temozolomide combined treatment.
    • To determine the 6 months Progression Free Survival.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histological proof of newly diagnosed glioblastoma,
    • Age: 18 and older,
    • Information to patient and signed consent form,
    • Indication for a « Stupp » protocol (cerebral focal radiotherapy and concomitant TMZ followed by adjuvant TMZ – 6 cycles),
    • Patient with grade 3 or 4 TP during Temozolomide chemotherapy, regardless of when the onset of TP was: after completion of concomitant RT/CT, before adjuvant CT or during adjuvant CT and only if a minimum of 2 cycles are still planned,
    • Normal initial platelets count (> 100 000/mm3) before the start of Temozolomide during the RT/CT concomitant phase,
    • Adequate haematological, renal, hepatic function at the time of inclusion visit,
    • ECOG PS 0-2 (patients unable to walk because of a paralysis and who are up in a wheel chair will be considered as ambulatory for the evaluation of the ECOG performance status),
    • Life expectancy > 2 months,
    • Patients covered by the French Health Insurance System,
    • Negative pregnancy test at the time of inclusion visit,
    • If required, effective contraception respecting criteria of CPMP/ICH/286/95 (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).
    E.4Principal exclusion criteria
    • Concomitant radiotherapy (Romiplostim will be started after the completion of the RT/CT concomitant phase),
    • Other malignancies (prior hx malignancies),
    • Any anterior systemic chemotherapy,
    • Any known coagulation disease or known haematological disease even if resolved. Known hypercoagulate state (e.g., factor V Leiden, protein C defiency, protein S deficiency, PT 20201, antiphospholipid antibody syndrome…),
    • Prior Romiplostim exposure or prior exposure to other TPO mimetics,
    • History of thromboembolic disease < 6 months. Treatment with anticoagulant such as Heparin or antivitamin K (LMWH as prophylactic treatment is authorized),
    • Any other hemato-toxicity (anemia, neutropenia) requiring EPO or GCSF,
    • Other causes of Temozolomide interruption (non haematological toxicities),
    • Known hypersensitivity to any E-coli derived product,
    • Participation to any other study during the last 30 days,
    • Refusal to give written informed consent,
    • Pregnancy or nursing,
    • For all men and women of childbearing potential: Refusal or inability to use effective means of contraception,
    • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial,
    • Persons protected by a legal regime (guardianship, trusteeship),
    • Patients in emergency situations,
    • Patients kept in detention.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients receiving 100% of the planned TMZ dosage in the whole Stupp protocol. The primary endpoint will consider dose reduction and dose delay.
    E.5.1.1Timepoint(s) of evaluation of this end point
    34 weeks
    E.5.2Secondary end point(s)
    • Incidence of serious adverse events according to CTCAE 4.0 criteria.
    • Incidence of chemotherapy cycles with dose reduction and reasons for dose reduction, incidence of postponed cycles of chemotherapy, reasons for delay and number of delayed days.
    • Number and percentage of patients with TP of grade 3 or grade 4 after receiving Romiplostim.
    • Number and percentage of patients receiving platelets transfusion for TP.
    • Incidence and type of adverse events linked to TP episodes during Romiplostim and Temozolomide combined treatment.
    • 6 months Progression Free Survival: The progression will be defined according to the RANO criteria. The progression will not be reported as an adverse event if it is related to the disease.
    E.5.2.1Timepoint(s) of evaluation of this end point
    34 weeks
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned2
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days15
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state35
    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 or care after the subject has ended the participation in the trial will be the expected normal treatment of that condition
    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 Decision2013-12-04
    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 StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-14
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