Clinical trial • Phase II/III • Oncology
LENVATINIB for Ewing sarcoma | Recurrent Ewing sarcoma | Primary refractory Ewing sarcoma
Phase II/III trial of LENVATINIB for Ewing sarcoma | Recurrent Ewing sarcoma | Primary refractory Ewing sarcoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Ewing sarcoma | Recurrent Ewing sarcoma | Primary refractory Ewing sarcoma
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 29-11-2024
Trial design
Randomised, open-label, arms referenced include ce, ifos and ifos-l (arm names referenced in protocol/endpoints); specific drug composition, doses and schedules per comparator arm are not specified in the provided json.-controlled Phase II/III trial in Austria, Belgium, Czechia and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arms referenced include CE, IFOS and IFOS-L (arm names referenced in protocol/endpoints); specific drug composition, doses and schedules per comparator arm are not specified in the provided JSON.
- Target Sample Size
- 276
Eligibility
Recruits 276 paediatric patients.
- Pregnancy Exclusion
- Pregnant or breastfeeding women.
- Vulnerable Population
- Vulnerable populations (children/adolescents) are included. The protocol requires "Written informed consent from the patient and/or parent/legal guardian." Age-specific patient information sheets and consent/assent forms are provided (children, adolescents, parents/guardians and adults) and country-specific versions are available per site/documents.
Inclusion criteria
- {"criterion_text":"- Histologically confirmed Ewing or Ewing-like sarcoma of the bone or soft tissues. Histological confirmation either at initial diagnosis or disease progression.\n- Patient agrees to use effective contraception during therapy and for 12 months after last trial treatment, where applicable.\n- For IFOS/IFOS-L randomisation only: Adequate liver function: bilirubin <3 x ULN and ALT or AST < 5 x ULN.\n- For IFOS/IFOS-L randomisation only: Left ventricular ejection fraction ≥50% at baseline as determined by echocardiography.\n- For IFOS/IFOS-L randomisation only: Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as: a. BP <95th percentile for sex, age, and height. Subjects >18 years of age should have BP ≤150/90 mm Hg at screening.\n- For IFOS/IFOS-L randomisation only: Urine dipstick <2+ for proteinuria. If ≥2+ proteinuria on dipstick, a spot urine protein:creatinine ratio test must be < CTCAE grade 2 Proteinuria.\n- Written informed consent from the patient and/or parent/legal guardian.\n- Radiological evidence of disease progression during or after completion of first or any subsequent line of treatment.\n- Age ≥ 2 years (* Trial sites in Austria will only recruit patients aged ≥2 years<30 years due to the conditional approval issued by their ethics committee).\n- Eligible for randomisation between at least two open study arms.\n- Adequate renal function defined as GFR ≥60 ml/min/1.73m2. If GFR is calculated and is <90 ml/min/1.73m2, an isotopic GFR should be performed to confirm adequate renal function.\n- Patient assessed as medically fit to receive trial treatment.\n- Date of planned randomisation within 4 weeks of baseline imaging.\n- Documented negative pregnancy test for female patients of childbearing potential."}
Exclusion criteria
- {"criterion_text":"- Absolute Neutrophil Count (ANC) <1.0 x 109/L or platelets <75 x 109/L.\n- Pre-existing medical condition that would necessitate a dose modification during cycle 1 as described in section 7 of the protocol.\n- Any central neurotoxicity with previous ifosfamide treatment.\n- For CE randomisation only: Carboplatin is contraindicated in patients with actively bleeding tumours. Therefore, patients with actively bleeding tumours are not eligible for the CE randomisation.\n- For IFOS/IFOS-L randomisation only: Clinically significant ECG abnormality, including a marked baseline prolonged QT or QTc interval (eg, a repeated demonstration of a QTc interval >480 msec).\n- For IFOS/IFOS-L randomisation only: History of aneurysm.\n- For IFOS/IFOS-L randomisation only: Arterial Thromboembolism in previous 6 months.\n- For IFOS/IFOS-L randomisation only: Gastrointestinal or non-gastrointestinal fistula.\n- For IFOS/IFOS-L randomisation only: Gastrointestinal bleeding or active haemoptysis within previous 3 weeks.\n- For IFOS/IFOS-L randomisation only: Major surgery within previous 3 weeks.\n- For IFOS/IFOS-L randomisation only: Previous treatment with tyrosine kinase inhibitors.\n- Clinical evidence of nephrotic syndrome.\n- For IFOS/IFOS-L randomisation only: Radiographic evidence of intratumoral cavitation, encasement, or invasion of a major blood vessel, or proximity to major blood vessels with potential risk of severe haemorrhage associated with tumor shrinkage/necrosis after lenvatinib therapy.\n- Follow-up not possible due to social, geographic or psychological reasons.\n- Previous randomisation into the rEECur trial.\n- Patients with a contraindication or hypersensitivity to any IMP may not be randomised to receive an arm that contains the contraindicated IMP.\n- Patients who have previously received one of the trial regimens off-trial may not be randomised to receive that regimen again. Patients who have had ifosfamide during first line therapy may receive the IFOS or IFOS-L arm. There is no requirement for a minimum time between receiving first line ifosfamide and entry to rEECur.\n- Cytotoxic chemotherapy or other investigational medicinal product (IMP) within previous two weeks.\n- Radiotherapy to target lesion within previous six weeks.\n- Pregnant or breastfeeding women."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event-free survival time (EFS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Objective imaging response (OR) according to RECIST 1.1 criteria after 2, 4, and 6 cycles for CE and after 2 and 4 cycles for IFOS and IFOS-L, and at the end of trial treatment for all arms","definition_or_measurement_approach":"Measured using RECIST 1.1 criteria at specified cycle timepoints (after 2, 4, 6 cycles as specified per arm and at end of treatment)."}
- {"endpoint_text":"- Progression-free survival time (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Overall survival time (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Toxicity, defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0 (see Appendix 2 of protocol)","definition_or_measurement_approach":"Adverse events graded using NCI CTCAE v4.0."}
- {"endpoint_text":"- PET-CT response after 4 cycles","definition_or_measurement_approach":""}
- {"endpoint_text":"- Quality of life (QoL)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Days spent in hospital","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 276
- Recruitment Window Months
- 194
- Consent Approach
- Written informed consent from the patient and/or parent/legal guardian is required. Age-specific information and consent/assent documents are provided (children, adolescents, parents/guardians, adults). Country/language-specific ICF/PIS documents are listed (examples: Austria - DE; Belgium - FR/NL; Czechia - CS; Denmark - DA; Finland - FI; France - FR; Italy - IT; Spain - ES; Netherlands - NL; Norway - NO).
Geography
- Total Number Of Sites
- 57
- Total Number Of Participants
- 436
Austria
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 33
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Klinische Abteilung für Pädiatrische Hämatologie/Onkologie
- Principal Investigator Name
- Martin Benesch
- Principal Investigator Email
- martin.benesch@medunigraz.at
- Contact Person Name
- Martin Benesch
- Contact Person Email
- martin.benesch@medunigraz.at
- Site Name
- Johannes Kepler University Linz
- Department Name
- Med Campus IV
- Principal Investigator Name
- Renate Steiner
- Principal Investigator Email
- renate.steiner@kepleruniklinikum.at
- Contact Person Name
- Renate Steiner
- Contact Person Email
- renate.steiner@kepleruniklinikum.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Pädiatrie I Department für Kinder- und Jugendheilkunde
- Principal Investigator Name
- Roman Crazzolara
- Principal Investigator Email
- roman.crazzolara@i-med.ac.at
- Contact Person Name
- Roman Crazzolara
- Contact Person Email
- roman.crazzolara@i-med.ac.at
- Site Name
- Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
- Department Name
- Kinderspital / Abteilung für Kinderund Jugendheilkunde
- Principal Investigator Name
- Gabriele Dobrovoljski
- Principal Investigator Email
- gabriele.dobrovoljski@salk.at
- Contact Person Name
- Gabriele Dobrovoljski
- Contact Person Email
- gabriele.dobrovoljski@salk.at
- Site Name
- St. Anna Kinderspital GmbH
- Department Name
- Hämato/Onkologie
- Principal Investigator Name
- Caroline Hutter
- Principal Investigator Email
- Caroline.hutter@stanna.at
- Contact Person Name
- Caroline Hutter
- Contact Person Email
- Caroline.hutter@stanna.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 29-11-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Hematologie Pediatrique
- Principal Investigator Name
- Benedicte Brichard
- Principal Investigator Email
- benedicte.brichard@uclouvain.be
- Contact Person Name
- Benedicte Brichard
- Contact Person Email
- benedicte.brichard@uclouvain.be
Czechia
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 03-12-2024
- Processing Time Days
- 34
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Department of Oncology and Radiotherapy
- Principal Investigator Name
- Katerina Kopeckova
- Principal Investigator Email
- katerina.kopeckova@fnmotol.cz
- Contact Person Name
- Katerina Kopeckova
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 29-11-2024
- Processing Time Days
- 30
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Department of Oncology
- Principal Investigator Name
- Bodil Engelmann
- Principal Investigator Email
- bodil.elisabeth.engelmann@regionh.dk
- Contact Person Name
- Bodil Engelmann
- Contact Person Email
- bodil.elisabeth.engelmann@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Department of Paediatrics and Adolescent Medicine
- Principal Investigator Name
- Henrik Hasle
- Principal Investigator Email
- henrik.hasle@skejby.rm.dk
- Contact Person Name
- Henrik Hasle
- Contact Person Email
- henrik.hasle@skejby.rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Paediatrics and Adolescent Medicine
- Principal Investigator Name
- Karsten Nysom
- Principal Investigator Email
- Karsten.nysom@regionh.dk
- Contact Person Name
- Karsten Nysom
- Contact Person Email
- Karsten.nysom@regionh.dk
- Site Name
- Region Midtjylland
- Department Name
- Department of Oncology
- Principal Investigator Name
- Ninna Aggerholm-Pedersen
- Principal Investigator Email
- ninnpede@rm.dk
- Contact Person Name
- Ninna Aggerholm-Pedersen
- Contact Person Email
- ninnpede@rm.dk
Finland
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 33
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- University Of Oulu
- Department Name
- Pediatrics
- Principal Investigator Name
- Elli-Maija Ukonmaanaho
- Principal Investigator Email
- elli-maija.ukonmaanaho@pohde.fi
- Contact Person Name
- Elli-Maija Ukonmaanaho
- Contact Person Email
- elli-maija.ukonmaanaho@pohde.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Ped hem-onc
- Principal Investigator Name
- Jukka Kanerva
- Principal Investigator Email
- jukka.kanerva@hus.fi
- Contact Person Name
- Jukka Kanerva
- Contact Person Email
- jukka.kanerva@hus.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Cancer Center
- Principal Investigator Name
- Susanna Mannisto
- Principal Investigator Email
- susanna.mannisto@hus.fi
- Contact Person Name
- Susanna Mannisto
- Contact Person Email
- susanna.mannisto@hus.fi
- Site Name
- Varsinais-Suomen hyvinvointialue
- Department Name
- Pediatrics
- Principal Investigator Name
- Anu Huurre
- Principal Investigator Email
- anu.huurre@varha.fi
- Contact Person Name
- Anu Huurre
- Contact Person Email
- anu.huurre@varha.fi
- Site Name
- Pirkanmaan hyvinvointialue
- Department Name
- Peditrics
- Principal Investigator Name
- Susanna Vuorenoja
- Principal Investigator Email
- susanna.vuorenoja@pirha.fi
- Contact Person Name
- Susanna Vuorenoja
- Contact Person Email
- susanna.vuorenoja@pirha.fi
France
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 33
- Number Of Sites
- 7
- Number Of Participants
- 88
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- nt de cancérologie de l’enfant et l’adolescent
- Principal Investigator Name
- Nathalie Gaspar
- Principal Investigator Email
- nathalie.gaspar@gustaveroussy.fr
- Contact Person Name
- Nathalie Gaspar
- Contact Person Email
- nathalie.gaspar@gustaveroussy.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Onco-hématologie pédiatrique
- Principal Investigator Name
- Natacha Entz-Werlé
- Principal Investigator Email
- Natacha.Entz-Werle@chru-strasbourg.fr
- Contact Person Name
- Natacha Entz-Werlé
- Contact Person Email
- Natacha.Entz-Werle@chru-strasbourg.fr
- Site Name
- Centre Leon Berard
- Department Name
- Paediatric oncology
- Principal Investigator Name
- Perrine Marec-Berard
- Principal Investigator Email
- perrine.marec-berard@ihope.fr
- Contact Person Name
- Perrine Marec-Berard
- Contact Person Email
- perrine.marec-berard@ihope.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Service d’immunologie, hématologie et oncologie pédiatrique
- Principal Investigator Name
- Andre Nicolas
- Principal Investigator Email
- nicolas.andre@ap-hm.fr
- Contact Person Name
- Andre Nicolas
- Contact Person Email
- nicolas.andre@ap-hm.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d'Hématologie et oncologie pédiatrique
- Principal Investigator Name
- Marie-Dominique Tabone
- Principal Investigator Email
- marie-dominique.tabone@trs.ap-hop-paris.fr
- Contact Person Name
- Marie-Dominique Tabone
- Contact Person Email
- marie-dominique.tabone@trs.ap-hop-paris.fr
- Site Name
- Hopital Des Enfants
- Department Name
- Pediatric oncology
- Principal Investigator Name
- Marie-Pierre Castex
- Principal Investigator Email
- castex.mp@chu-toulouse.fr
- Contact Person Name
- Marie-Pierre Castex
- Contact Person Email
- castex.mp@chu-toulouse.fr
- Site Name
- CHU Besancon
- Department Name
- Hématologie oncologie pédiatrique
- Principal Investigator Name
- Natacha Entz-Werle
- Principal Investigator Email
- Natacha.Entz-Werle@chru-strasbourg.fr
- Contact Person Name
- Natacha Entz-Werle
- Contact Person Email
- Natacha.Entz-Werle@chru-strasbourg.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 04-12-2024
- Processing Time Days
- 35
- Number Of Sites
- 10
- Number Of Participants
- 102
Sites
- Site Name
- Istituto Ortopedico Rizzoli
- Department Name
- SC Osteoncology Unit
- Principal Investigator Name
- Toni Ibrahim
- Principal Investigator Email
- toni.ibrahim@ior.it
- Contact Person Name
- Toni Ibrahim
- Contact Person Email
- toni.ibrahim@ior.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SC Oncologia Medica dei Tumori Mesenchimali dell’Adulto
- Principal Investigator Name
- Rossella Bertulli
- Principal Investigator Email
- rossella.bertulli@istitutotumori.mi.it
- Contact Person Name
- Rossella Bertulli
- Contact Person Email
- rossella.bertulli@istitutotumori.mi.it
- Site Name
- I.F.O. Istituti Fisioterapici Ospitalieri
- Department Name
- UOSD Sarcomi e Tumori Rari
- Principal Investigator Name
- Virginia Ferraresi
- Principal Investigator Email
- virginia.ferraresi@ifo.it
- Contact Person Name
- Virginia Ferraresi
- Contact Person Email
- virginia.ferraresi@ifo.it
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- Dipartimento di Oncoematologia e Terapia
- Principal Investigator Name
- Giuseppe Maria Milano
- Principal Investigator Email
- Giuseppemaria.milano@opbg.net
- Contact Person Name
- Giuseppe Maria Milano
- Contact Person Email
- Giuseppemaria.milano@opbg.net
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- SC oncoematologia pediatrica
- Principal Investigator Name
- Franca Fagioli
- Principal Investigator Email
- franca.fagioli@unito.it
- Contact Person Name
- Franca Fagioli
- Contact Person Email
- franca.fagioli@unito.it
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- Dipartimento di Oncoematologia Pediatrica e Cure Domiciliari
- Principal Investigator Name
- Angela Tamburini
- Principal Investigator Email
- angela.tamburini@meyer.it
- Contact Person Name
- Angela Tamburini
- Contact Person Email
- angela.tamburini@meyer.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Pediatric Onco-Hematology Unit
- Principal Investigator Name
- Luca Coccoli
- Principal Investigator Email
- l.coccoli@ao-pisa.toscana.it
- Contact Person Name
- Luca Coccoli
- Contact Person Email
- l.coccoli@ao-pisa.toscana.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SC pediatria Oncologica
- Principal Investigator Name
- Roberto Luksch
- Principal Investigator Email
- roberto.Luksch@istitutotumori.mi.it
- Contact Person Name
- Roberto Luksch
- Contact Person Email
- roberto.Luksch@istitutotumori.mi.it
- Site Name
- Azienda Ospedaliera Santobono Pausilipon
- Department Name
- Department of Oncology, Hematology and Cell Therapies
- Principal Investigator Name
- Massimo Eraldo Abate
- Principal Investigator Email
- massimoeraldo.abate@santobonopausilipon.it
- Contact Person Name
- Massimo Eraldo Abate
- Contact Person Email
- massimoeraldo.abate@santobonopausilipon.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Oncoematologia Pediatrica
- Principal Investigator Name
- Marta Pierobon
- Principal Investigator Email
- marta.pierobon@aopd.veneto.it
- Contact Person Name
- Marta Pierobon
- Contact Person Email
- marta.pierobon@aopd.veneto.it
Spain
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 03-12-2024
- Processing Time Days
- 34
- Number Of Sites
- 18
- Number Of Participants
- 150
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pilar Blay
- Principal Investigator Email
- pilarblayalbors@gmail.com
- Contact Person Name
- Pilar Blay
- Contact Person Email
- pilarblayalbors@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Paediatric Oncology
- Principal Investigator Name
- Laura García Hidalgo
- Principal Investigator Email
- laura_garcia_hidalgo@hotmail.com
- Contact Person Name
- Laura García Hidalgo
- Contact Person Email
- laura_garcia_hidalgo@hotmail.com
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Rosa Álvarez
- Principal Investigator Email
- rosa.alvarez.al@gmail.com
- Contact Person Name
- Rosa Álvarez
- Contact Person Email
- rosa.alvarez.al@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Javier Martin
- Principal Investigator Email
- jmartin@atbsarc.org
- Contact Person Name
- Javier Martin
- Contact Person Email
- jmartin@atbsarc.org
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Medical Oncology
- Principal Investigator Name
- Claudia Valverde
- Principal Investigator Email
- cvalverde@vhio.net
- Contact Person Name
- Claudia Valverde
- Contact Person Email
- cvalverde@vhio.net
- Site Name
- Hospital Infantil Universitario Nino Jesus
- Department Name
- Medical Oncology
- Principal Investigator Name
- Alba Rubio
- Principal Investigator Email
- alba.rubio@salud.madrid.org
- Contact Person Name
- Alba Rubio
- Contact Person Email
- alba.rubio@salud.madrid.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Medical Oncology
- Principal Investigator Name
- María Ángeles Vaz
- Principal Investigator Email
- mavaz4@gmail.com
- Contact Person Name
- María Ángeles Vaz
- Contact Person Email
- mavaz4@gmail.com
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Medical Oncology
- Principal Investigator Name
- Javier Martínez Trufero
- Principal Investigator Email
- oncojmt@gmail.com
- Contact Person Name
- Javier Martínez Trufero
- Contact Person Email
- oncojmt@gmail.com
- Site Name
- Hospital Universitario De Canarias
- Department Name
- Medical Oncology
- Principal Investigator Name
- Josefina Cruz
- Principal Investigator Email
- jcruzjurado@gmail.com
- Contact Person Name
- Josefina Cruz
- Contact Person Email
- jcruzjurado@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pilar Sancho
- Principal Investigator Email
- mariap.sancho.sspa@juntadeandalucia.es
- Contact Person Name
- Pilar Sancho
- Contact Person Email
- mariap.sancho.sspa@juntadeandalucia.es
- Site Name
- University Hospital Son Espases
- Department Name
- Medical Oncology
- Principal Investigator Name
- Pablo Luna
- Principal Investigator Email
- pablo.luna@ssib.es
- Contact Person Name
- Pablo Luna
- Contact Person Email
- pablo.luna@ssib.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Medical Oncology
- Principal Investigator Name
- Roberto Díaz-Beveridge
- Principal Investigator Email
- robertdiazbeveridge@gmail.com
- Contact Person Name
- Roberto Díaz-Beveridge
- Contact Person Email
- robertdiazbeveridge@gmail.com
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Xavier García del Muro
- Principal Investigator Email
- garciadelmuro@iconcologia.net
- Contact Person Name
- Xavier García del Muro
- Contact Person Email
- garciadelmuro@iconcologia.net
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Medical Oncology
- Principal Investigator Name
- Raúl Terés
- Principal Investigator Email
- rteres@santpau.cat
- Contact Person Name
- Raúl Terés
- Contact Person Email
- rteres@santpau.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andrés Redondo
- Principal Investigator Email
- aredondo@gmail.com
- Contact Person Name
- Andrés Redondo
- Contact Person Email
- aredondo@gmail.com
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Medical Oncology
- Principal Investigator Name
- Isabel Sevilla
- Principal Investigator Email
- isevilla02@yahoo.es
- Contact Person Name
- Isabel Sevilla
- Contact Person Email
- isevilla02@yahoo.es
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Medical Oncology
- Principal Investigator Name
- Natalia Fuente
- Principal Investigator Email
- NATALIA.FUENTEFERNANDEZ@osakidetza.eus
- Contact Person Name
- Natalia Fuente
- Contact Person Email
- NATALIA.FUENTEFERNANDEZ@osakidetza.eus
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Paediatric Oncology
- Principal Investigator Name
- Jaume Mora
- Principal Investigator Email
- Jmora@hsjdbcn.es
- Contact Person Name
- Jaume Mora
- Contact Person Email
- Jmora@hsjdbcn.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 04-12-2024
- Processing Time Days
- 35
- Number Of Sites
- 2
- Number Of Participants
- 11
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Suzanne Kaal
- Principal Investigator Email
- Suzanne.Kaal@radboudumc.nl
- Contact Person Name
- Suzanne Kaal
- Contact Person Email
- Suzanne.Kaal@radboudumc.nl
- Site Name
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Department Name
- Solid Tumours
- Principal Investigator Name
- Hans Merks
- Principal Investigator Email
- J.H.M.Merks@prinsesmaximacentrum.nl
- Contact Person Name
- Hans Merks
- Contact Person Email
- J.H.M.Merks@prinsesmaximacentrum.nl
Norway
- Earliest CTIS Part Ii Submission Date
- 30-10-2024
- Latest Decision Or Authorization Date
- 29-11-2024
- Processing Time Days
- 30
- Number Of Sites
- 4
- Number Of Participants
- 20
Sites
- Site Name
- Universitetssykehuset Nord-Norge HF
- Department Name
- Department of Oncology
- Principal Investigator Name
- Eivind Smeland
- Principal Investigator Email
- Eivind.smeland@unn.no
- Contact Person Name
- Eivind Smeland
- Contact Person Email
- Eivind.smeland@unn.no
- Site Name
- St. Olavs Hospital HF
- Department Name
- Oncology department
- Principal Investigator Name
- Heidi Knobel
- Principal Investigator Email
- Heidi.Knobel@stolav.no
- Contact Person Name
- Heidi Knobel
- Contact Person Email
- Heidi.Knobel@stolav.no
- Site Name
- Helse Bergen HF
- Department Name
- Department of Oncology
- Principal Investigator Name
- Dorota Malgorzata Wojcik
- Principal Investigator Email
- Dorota.malgorzata.wojcik@helse-bergen.no
- Contact Person Name
- Dorota Malgorzata Wojcik
- Contact Person Email
- Dorota.malgorzata.wojcik@helse-bergen.no
- Site Name
- Oslo University Hospital HF
- Department Name
- Oncology Department
- Principal Investigator Name
- Kjetil Boye
- Principal Investigator Email
- pkb@ous-hf.no
- Contact Person Name
- Kjetil Boye
- Contact Person Email
- pkb@ous-hf.no
Sponsor
Primary sponsor
- Full Name
- The University Of Birmingham
- Organisation Type
- Educational Institution
- Country Of Registered Address
- United Kingdom
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"code:1","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"St James's University Hospital","duties_or_roles":"codes:15 (Biobank), 4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United Kingdom","full_name":"The Christie NHS Foundation Trust","duties_or_roles":"codes:15 (Biobank), 4","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- LENVIMA 4 mg hard capsules
- Active Substance
- LENVATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation EU/1/15/1002/001
- Maximum Dose
- 24 mg
- Investigational Product Name
- LENVIMA 10 mg hard capsules
- Active Substance
- LENVATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Marketing authorisation EU/1/15/1002/002
- Maximum Dose
- 24 mg
- Investigational Product Name
- GEMCITABINE
- Active Substance
- GEMCITABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 900 mg/m2
- Investigational Product Name
- TEMOZOLOMIDE
- Active Substance
- TEMOZOLOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 3 gm/m2
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 400 mg/m2
- Investigational Product Name
- ETOPOSIDE PHOSPHATE
- Active Substance
- ETOPOSIDE PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 136.32 mg/m2
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 120 mg/m2
- Investigational Product Name
- IRINOTECAN
- Active Substance
- IRINOTECAN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 50 mg/m2
- Investigational Product Name
- TOPOTECAN
- Active Substance
- TOPOTECAN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 0.75 mg/m2
- Investigational Product Name
- DOCETAXEL / ANHYDROUS DOCETAXEL
- Active Substance
- DOCETAXEL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 80 mg/m2
- Investigational Product Name
- CYCLOPHOSPHAMIDE
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Not authorised (marketingAuthNumber: -)
- Maximum Dose
- 250 mg/m2
- Combination Treatment
- Yes
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