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    Summary
    EudraCT Number:2021-004792-14
    Sponsor's Protocol Code Number:0298-21
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2021-09-08
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2021-004792-14
    A.3Full title of the trial
    A Randomized, Active-Controlled, Multicenter, Open label, Two Arm Study to Assess Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics with Pegfilgrastim PFS of Intas Pharmaceutical Limited Compared with Neupogen® Injection in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Pegfilgrastim PFS in Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen.
    A.4.1Sponsor's protocol code number0298-21
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/206/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIntas Pharmaceuticals Ltd.
    B.1.3.4CountryIndia
    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 supportIntas Pharmaceuticals Ltd
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIntas Pharmaceuticals Ltd
    B.5.2Functional name of contact pointDr. Pravin Ghadge
    B.5.3 Address:
    B.5.3.1Street AddressCorporate House, Nr. Sola Bridge, S.G. Highway,Thaltej
    B.5.3.2Town/ cityAhmedabad
    B.5.3.3Post code380054
    B.5.3.4CountryIndia
    B.5.4Telephone number912717660100
    B.5.5Fax number912717660105
    B.5.6E-mailPravin_ghadge@intaspharma.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 namePegfilgrastim Pre-filled syringe for Injection 1.5mgper0.15 mL,2.5 mg per 0.25 mL and4.0 mg per0.4ml
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation Yes
    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 INNPegfilgrastim
    D.3.9.1CAS number 208265-92-3
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Yes
    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 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 Neupogen Singleject (Filgrastim) 30 MU (0.6 mg/mL)
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Ltd. (Europe)
    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 nameNeupogen Singleject (Filgrastim)30 MU (0.6 mg/mL)
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation Yes
    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 INNFilgrastim
    D.3.9.1CAS number 121181-53-1
    D.3.9.4EV Substance CodeSUB07627MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.6
    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
    Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen
    E.1.1.1Medical condition in easily understood language
    Not Any
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10047954
    E.1.2Term White blood cell disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy of a subcutaneous (SC) dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT
    E.2.2Secondary objectives of the trial
    Assess the pharmacodynamics, pharmacokinetics, safety, and tolerability including local (injection site) tolerability of a single SC dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female infants and children from under 6 years of age
    2.Children with a pathologically confirmed diagnosis of rhabdomyosarcoma or high-risk Wilms’ tumour, planned for treatment with 1 of the following CmT regimens:
    • Rhabdomyosarcoma:
    − Ifosfamide plus vincristine plus actinomycin D (IVA)
    − Ifosfamide plus vincristine plus actinomycin D plus doxorubicin (IVADo)
    − Vincristine plus actinomycin D plus cyclophosphamide (VAC)
    • High-risk Wilms’ tumour:
    − Cyclophosphamide with doxorubicin and /or etoposide with carboplatin
    3. Written informed consent provided by parent(s)/legal representative(s) of the paediatric participant and participant’s assent if able to understand and/or follow study instructions alone or with parental assistance
    4. Parents / legally acceptable representative should have signed consent for a CmT regimen that is known to be myelotoxic, with counts expected to drop below an absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days.
    5. ANC and platelet count: Participants must have an ANC >1 × 109/L and a pl
    atelet count >100 × 109/L to be eligible for therapy at the start of CmT
    6.Normal cardiac, renal, and hepatic function
    7.All participants must have a life expectancy of >4 months in the opinion of the investigator
    8.On-treatment Eastern Cooperative Oncology Group (ECOG) performance status ≤2
    9.Participants with baseline laboratory values acceptable for them to receive chemotherapy
    E.4Principal exclusion criteria
    Any potential participant who meets any of the following criteria will be excluded from participating in the study:
    1.Known hypersensitivity to any component of this product.
    2.Previous treatment with long-acting G-CSF
    3.History of congenital neutropenia or cyclic neutropenia
    4.Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint
    5.Bone marrow involvement
    6.Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow (e.g., whole pelvic radiation) for any reason, or any therapeutic radiation within the 4 weeks prior to the first dose
    7.Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit
    8.A positive polymerase chain reaction test for COVID-19.
    9.Treatment with lithium at screening or planned during the study
    10.Participation in an interventional clinical study within 30 days or 5 half-lives of the investigational product before enrollment, whichever is longer
    11.Participants with autoimmune diseases
    12.Participants with severe liver, kidney, heart, or lung dysfunction precluding the expected delivery of the intended chemotherapy regimen
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of a single subcutaneous (SC) dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Incidence and duration of severe neutropenia (ANC <0.5 × 109/L) in each chemotherapy cycle.
    • Incidence and duration of very severe neutropenia (ANC <0.1 × 109/L) in each chemotherapy cycle.
    • Incidence of febrile neutropenia (body temperature >38.3°C or 2 consecutive readings higher than 37.8°C measured at the axilla or external ear at least 2 hours apart; and ANC <0.5 × 10^9 /L per chemotherapy cycle and across all chemotherapy cycles.
    • Area under the curve (AUC) of absolute neutrophil count (AUCANC) in a chemotherapy cycle.
    ANC nadir (measured in 10^9/L), which is the lowest ANC recorded across all cycles.
    E.5.2Secondary end point(s)
    To assess the pharmacodynamics, pharmacokinetics, safety, and tolerability including local (injection site) tolerability of a single SC dose administration of pegfilgrastim per chemotherapy cycle compared to daily SC dose administrations of filgrastim in children receiving CmT
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Total time (days) in Intensive Care Unit (ICU) across all cycles
    • Percentage of scheduled chemotherapy dose that was delivered across all cycles
    • Proportion with chemotherapy doses reduced, omitted, or delayed across all cycles
    • Time in days in hospital and time in the ICU due to FN or associated infections across all cycles
    • Number of days of delay of chemotherapy across all cycles
    • Occurrence and/or resolution of chemotherapy-induced mucositis across all cycles
    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 Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Neupogen Singleject (Filgrastim) Solution for injection in a pre-filled syringe 30 MU (0.6 mg/mL)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    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
    Last visit of last subjects
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 12
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric Patients (0 to 6 years of age)
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Paediatric Patients
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Mahatma Gandhi Cancer Hospital & research Institute
    G.4.3.4Network Country India
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Kiran Hospital Multisuper speciality hospital& research Centre
    G.4.3.4Network Country India
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Deenanath Mangeshkar Hospital
    G.4.3.4Network Country India
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Sir Ganga Ram Hospital
    G.4.3.4Network Country India
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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