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Clinical trials for Actinomycin

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   44335   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
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    16 result(s) found for: Actinomycin. Displaying page 1 of 1.
    EudraCT Number: 2005-002996-34 Sponsor Protocol Number: PK 2005 xx Start Date*: 2006-04-27
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: Pharmacokinetics of actinomycin D in children with cancer
    Medical condition: Any children's cancer where this drug is administered as part of the treatment regimen
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000693-18 Sponsor Protocol Number: ActD-AML-PG01 Start Date*: 2014-05-27
    Sponsor Name:Dipartimento di Medicina, Università di Perugia
    Full Title: A PHASE II STUDY OF THE CLINICAL ACTIVITY AND SAFETY OF ACTINOMYCIN D IN PATIENTS WITH RELAPSED/REFRACTORY ACUTE MYELOID LEUKEMIA WITH NUCLEOPHOSMIN (NPM1) GENE MUTATION
    Medical condition: Relapsed/refractory acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003490-41 Sponsor Protocol Number: AML-PG02 Start Date*: 2016-09-09
    Sponsor Name:PROF.BRUNANGELO FALINI,DR.SSA MARIA PAOLA MARTELLI,UNIVERSITA' DI PERUGIA
    Full Title: A PHASE 2A STUDY ON THE CLINICAL ACTIVITY AND SAFETY OF ACTINOMYCIN-D IN PATIENTS WITH NPM1-MUTATED AML AGED =70 YEARS AND/OR UNFIT FOR INTENSIVE CHEMOTHERAPY, EITHER NEWLY DIAGNOSED OR PREVIOUSLY ...
    Medical condition: NPM1-MUTATED AML NEWLY DIAGNOSED OR PREVIOUSLY TREATED WITH HYPOMETHYLATING AGENTS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000282-68 Sponsor Protocol Number: AML-PG03 Start Date*: 2017-12-20
    Sponsor Name:PROF.BRUNANGELO FALINI,DR.SSA MARIA PAOLA MARTELLI,UNIVERSITA' DI PERUGIA
    Full Title: A phase 2a study of the clinical activity and safety of actinomycin D in patients with NPM1-wild type AML (other than APL) aged = 70 years old and/or unfit for intensive chemotherapy, either newly ...
    Medical condition: patients with NPM1-wild type AML (other than APL) aged >= 70 years old and/or unfit for intensive chemotherapy, either newly diagnosed or previously treated with hypometylating agents
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-022795-31 Sponsor Protocol Number: TE 2010-12 Start Date*: 2012-02-20
    Sponsor Name:Barts and the London NHS Trust
    Full Title: A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours with Poor Prognosis
    Medical condition: Relapsed Germ Cell Tumour with poor prognosis
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000087-34 Sponsor Protocol Number: XM22-08 Start Date*: 2015-06-05
    Sponsor Name:Merckle GmbH
    Full Title: An Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Lipegfilgrastim 100 μg/kg B...
    Medical condition: Neutropenia in pediatric patients diagnosed with Ewing family of Tumors or rhabdomyosarcoma receiving chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10029354 Neutropenia PT
    19.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) SK (Completed) CZ (Completed) BG (Completed) DE (Ongoing) ES (Completed) RO (Completed) PL (Completed) BE (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2021-004792-14 Sponsor Protocol Number: 0298-21 Start Date*: 2021-09-08
    Sponsor Name:Intas Pharmaceuticals Ltd.
    Full Title: A Randomized, Active-Controlled, Multicenter, Open label, Two Arm Study to Assess Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics with Pegfilgrastim PFS of Intas Pharmaceutical Limited Com...
    Medical condition: Paediatric Patients Under 6 years of Age with Rhabdomyosarcoma or Wilms’ Tumour on Myelosuppressive Chemotherapy (CmT) Regimen
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10047954 White blood cell disorders HLGT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2008-005295-27 Sponsor Protocol Number: TE 2008 01 Start Date*: 2009-05-14
    Sponsor Name:Barts and The London NHS Trust
    Full Title: A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURS WITH POOR PROGNOSIS
    Medical condition: Relapsed Germ Cell Tumour with poor prognosis
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004742-18 Sponsor Protocol Number: XM22-07 Start Date*: 2012-04-04
    Sponsor Name:Merckle GmbH, a member of the ratiopharm group, a subsidiary of Teva Pharmaceutical Industries Ltd. Germany
    Full Title: Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children wit...
    Medical condition: Children with Ewing Family of Tumors or Rhabdomyosarcoma receiving cytotoxic Chemotherapy for malignancy inducing neutropenia
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003335-29 Sponsor Protocol Number: SIOPEATRT01 Start Date*: 2021-04-15
    Sponsor Name:German Pediatric Oncology Group, GPOH gGmbH
    Full Title: An international prospective umbrella trial for children with atypical teratoid/rhabdoid tumours (ATRT) including A randomized phase III study evaluating the non-inferiority of three courses of hig...
    Medical condition: atypical teratoid/rhabdoid tumours (ATRT)
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) NO (Trial now transitioned) NL (Trial now transitioned) DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000515-24 Sponsor Protocol Number: RG_17-247 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Birmingham
    Full Title: FaR-RMS: An overarching study for children and adults with Frontline and Relapsed RhabdoMyoSarcoma
    Medical condition: Rhabdomyosarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10039022 Rhabdomyosarcoma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) NO (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DK (Trial now transitioned) SI (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) FR (Trial now transitioned) SE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000533-13 Sponsor Protocol Number: Randomet2017 Start Date*: 2019-12-05
    Sponsor Name:Gesellschaft für Pädiatrische Onkologie und Hämatologie gGmbH
    Full Title: Randomized multi-centre open-label non-inferiority phase 3 clinical trial for patients with a stage IV childhood renal tumour comparing upfront Vincristine, Actinomycin-D and Doxorubicin (VAD, stan...
    Medical condition: Stage IV childhood renal tumours
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) CZ (Ongoing) DK (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005432-28 Sponsor Protocol Number: NEUGR-005 Start Date*: 2013-10-15
    Sponsor Name:Teva Pharmaceuticals Industries Ltd.
    Full Title: An open label, randomized, active controlled, dose finding study to evaluate the pharmacodynamics, pharmacokinetics, efficacy and safety of balugrastim at doses of 300 μg/kg and 670 μg/kg in pediat...
    Medical condition: Neutropenia induced by chemotherapy in patients with solid tumors
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10065252 Solid tumor LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Completed) BG (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-003658-13 Sponsor Protocol Number: EWING2008 Start Date*: 2009-03-19
    Sponsor Name:Universitaetsklinikum Muenster
    Full Title: EWING 2008
    Medical condition: Ewing sarcoma Malignant peripheral neuroectodermal tumour Askin tumour Atypical Ewing sarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057846 Primitive neuroectodermal tumour PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10057656 Askin's tumour LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015759 Extra-osseous Ewing's sarcoma PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015560 Ewing's sarcoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) BE (Completed) NL (Completed) SE (Completed) HU (Completed) FI (Completed) LT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2012-002107-17 Sponsor Protocol Number: RG_11-152 Start Date*: 2013-02-01
    Sponsor Name:University of Birmingham
    Full Title: International Randomised Controlled Trial for the Treatment of Newly Diagnosed Ewing's Sarcoma Family of Tumours
    Medical condition: Ewing's Sarcoma Family of Tumours
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015560 Ewing's sarcoma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) BE (Completed) CZ (Completed) IE (Completed) HU (Completed) NL (Completed) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000217-35 Sponsor Protocol Number: EpSSG RMS 2005 Start Date*: Information not available in EudraCT
    Sponsor Name:Rikshospitalet-Radiumhospitalet HF
    Full Title: EpSSG RMS 2005 a protocol for non metastatic rhabdomyosarcoma
    Medical condition: Rhabdomyosarkom (RMS) er en kreftform utgående fra muskelvev. RMS kan oppstå hvor som helst i kroppen og rammer folk i alle aldre. Behandlingen av RMS består av cellegift, operasjon og/eller strål...
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NO (Ongoing) NL (Completed) BE (Completed) IT (Ongoing) GB (GB - no longer in EU/EEA) IE (Completed) ES (Ongoing)
    Trial results: (No results available)
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    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.

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