Clinical trial • Phase I/II • Oncology

Temozolomide for Neuroblastoma (relapsed, high-risk)

Phase I/II trial of Temozolomide for Neuroblastoma (relapsed, high-risk).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Neuroblastoma (relapsed, high-risk)
Trial Stage
Phase I/II
Drug Modality
Small molecule|Monoclonal antibody
Paediatric Trial
Yes
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
08-04-2025
First CTIS Authorization Date
28-07-2025

Trial design

Randomised, current best available treatment / standard of care (not further specified in provided data)-controlled, adaptive Phase I/II trial in Spain, Netherlands, Austria and others.

Randomised
Yes
Comparator
Current best available treatment / standard of care (not further specified in provided data)
Adaptive
True, multi-arm multi-stage platform design with Tier 1 randomised comparison and Tier 2 dose-escalation and dose-expansion/confirmation cohorts
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
52

Eligibility

Recruits 52 paediatric patients.

Pregnancy Exclusion
Pregnant or lactating participant
Vulnerable Population
Includes paediatric participants (age ≥1 year) and adolescents; consent must be signed by participant, parent or guardian. Age-specific informed consent and assent materials are provided (multiple assent and ICF documents listed for age groups such as 5-9, 8-11, 10-13, 12-15, 15-17, 16+, parent/guardian ICFs) in multiple country/language versions.

Inclusion criteria

  • {"criterion_text":"- Disease specific: Histologically proven neuroblastoma as per International Neuroblastoma Staging System (INSS) definition"}
  • {"criterion_text":"- Performance and organ function: Liver function (within 72 hours prior to randomisation) - Absence of clinically significant signs of liver dysfunction. AST or ALT ≤ 3.0 ULN and total bilirubin ≤ 1.5 ULN. In patients with liver metastases, AST or ALT ≤ 5 ULN and total bilirubin ≤ 2.5 ULN is allowed"}
  • {"criterion_text":"- Performance and organ function: Coagulation - Participants must not have an active uncontrolled coagulopathy. Anticoagulation is permitted as long as the INR or APTT is within therapeutic limits (according to the medical standard of the institution) and the participant has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment."}
  • {"criterion_text":"- Performance and organ function: Blood pressure below 95th centile for age and sex. Participants ≥18 years of age should have a blood pressure ≤150/90 mmHg (within 72 hours prior to randomisation). Use of antihypertensive medication is permitted."}
  • {"criterion_text":"- Tier 2 Specific Inclusion Criteria: More than one relapse event or ineligible for Tier 1. NB - The following previous treatments are allowed provided that the principal investigator expects a favourable benefit/risk assessment (e.g. patients could derive potential benefit from the Tier 2 combination): bevacizumab, any anti-GD2 antibody given with chemotherapy (‘chemo-immunotherapy’) and previous treatment with temozolomide with irinotecan"}
  • {"criterion_text":"- Disease Specific: High risk relapsed neuroblastoma (relapsed or progressed after being defined as High Risk at any time following diagnosis or progressed/relapsed as high-risk neuroblastoma)"}
  • {"criterion_text":"- Disease Specific: Measurable disease by cross sectional imaging or evaluable disease (uptake on MIBG scan with or without bone marrow histology), as per INRC [2, 3]. Participants with only bone marrow detectable disease (bone marrow aspirate or trephine) are NOT eligible for the study"}
  • {"criterion_text":"- General: Age ≥1 year"}
  • {"criterion_text":"- General: Signed informed consent from participant, parent or guardian"}
  • {"criterion_text":"- Performance and organ function: Performance Status - Lansky (for patients ≤12 years of age) or Karnofsky (for those >12) ≥ 50%, (Participants who are unable to walk because of paralysis, but who are able to sit upright unassisted in a wheelchair, will be considered ambulatory for the purpose of assessing performance score)"}
  • {"criterion_text":"- Performance and organ function: Life expectancy of ≥12 weeks"}
  • {"criterion_text":"- Performance and organ function: Bone marrow function (within 72 hours prior to randomisation) - Platelets ≥ 50 x 109/L (unsupported for 72 hours), ANC ≥ 0.50 x 109/L (no G-CSF support for 72 hours) and Haemoglobin > 8 g/dL (transfusions allowed)"}
  • {"criterion_text":"- Performance and organ function: Renal function (within 72 hours prior to randomisation) - Absence of clinically significant proteinuria (either early morning urine dipstick ≤ 2+) or if dipstick urinalysis shows > 2+ proteinuria, protein: creatinine (Pr/Cr) ratio must be < 0.5 or a 24 hour protein excretion must be < 0.5g and Serum creatinine ≤ 1.5 ULN for age, if higher, a measured GFR (radioisotope or 24 hour urine calculated creatinine clearance) must be ≥ 60 ml/min/1.73 m2"}

Exclusion criteria

  • {"criterion_text":"- Known contraindication or hypersensitivity to: Any study drug or component of the formulation, Chinese hamster ovary products or other recombinant human or humanised antibodies and Participants with mild previous hypersensitivity reactions to anti-GD2 antibodies may be included, but those with severe (or G4) hypersensitivity reactions to anti-GD2 antibodies will be excluded."}
  • {"criterion_text":"- Bleeding metastases (participants with CNS metastases can be enrolled as long as the metastases are not bleeding). At least 6 months from any ≥ G3 haemoptysis or pulmonary haemorrhage"}
  • {"criterion_text":"- Use of enzyme inducing anticonvulsants within 72hr of start of trial treatment"}
  • {"criterion_text":"- Conditions that increase the risk of bevacizumab-related toxicities: History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e. in the absence of therapeutic anticoagulation), History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding within 6 months prior to study enrolment and Current chronic intestinal inflammatory disease/bowel obstruction"}
  • {"criterion_text":"- Intolerance to galactose and fructose, lactase deficiency, and/or defect of absorption of galactose and fructose"}
  • {"criterion_text":"- Males or females of reproductive potential may not participate unless they agree to use a highly effective method of birth control, i.e. with a failure rate of less than 1% per year, (e.g. implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner), for the duration of study therapy and for up to 6 months after the last dose of trial drugs. A negative urine or serum pregnancy test must be obtained within 72 hours prior to dosing in females who are post-menarche."}
  • {"criterion_text":"- Pregnant or lactating participant"}
  • {"criterion_text":"- Live or live-attenuated vaccines given within previous 28 days prior to study enrolment"}
  • {"criterion_text":"- Any uncontrolled medical condition that poses an additional risk to the participant"}
  • {"criterion_text":"- Tier 1 Specific Exclusion Criteria: More than one relapse event after the start of high risk neuroblastoma therapy"}
  • {"criterion_text":"- Tier 1 Specific Exclusion Criteria: Previous treatments that are not allowed - Bevacizumab for relapsed neuroblastoma. Patients who have received BIT for refractory disease are not excluded, providing no progression of disease during this treatment occurred and Treatment with any anti-GD2 antibody given with chemotherapy (‘chemo-immunotherapy’) for treatment of relapsed neuroblastoma. Prior treatment with chemo-immunotherapy for refractory disease is allowed, provided no disease progression during this therapy."}
  • {"criterion_text":"- Clinically significant neurological toxicity, uncontrolled seizures or objective peripheral neuropathy (> grade 2). (Unresolved neurological deficits from previous spinal cord compression or surgeries are acceptable). Participants with previous ≥ Grade 3 motor neurotoxicity secondary to anti-GD2 are excluded, even if recovered."}
  • {"criterion_text":"- Prior severe arterial thrombo-embolic events (e.g. cardiac ischemia, cerebral vascular accident, peripheral arterial thrombosis) or any ongoing arterial thrombo-embolic events"}
  • {"criterion_text":"- A history of (noninfectious) pneumonitis requiring steroids, or current pneumonitis."}
  • {"criterion_text":"- Patients that are allergic to all therapies for Pnemocystis jirovecii pneumonia and can thus not receive prophylaxis for PJP."}
  • {"criterion_text":"- Uncontrolled infection"}
  • {"criterion_text":"- Inadequate recovery from prior surgery with ongoing ≥ Grade 3 surgical complications. Grade ≥ 2 wound dehiscence."}
  • {"criterion_text":"- Recent surgical procedures (at start of trial treatment). Patient can be randomised up to 48hr prior to these periods being completed provided that trial treatment only starts after complying with all of them: Core biopsies within previous 24hr, Open excisional biopsies within previous 48hr, Major surgery within previous 2 weeks, Bone marrow aspirates/trephines, within previous 48hr and Tunnelled central line insertion within previous 48hr"}
  • {"criterion_text":"- Washout from prior treatments (at start of trial treatment): Chemotherapy within previous 2 weeks (1 week for oral metronomic chemotherapy regimens), Any anti-GD2 therapy within previous 2 weeks, Craniospinal radiotherapy or MIBG therapy within previous 6 weeks, Radiotherapy to the tumour bed within previous 2 weeks (no washout for palliative radiotherapy), Myeloablative therapy with haematopoietic stem cell rescue (autologous stem cell transplant) within previous 8 weeks, Allogeneic stem cell transplant within previous 12 weeks (with absence of active ≥ G2 acute GVHD) and 14 days or 5 half-lives (whichever occurs later) from last administration of an IMP in an IMP-trial"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-Free Survival time (as per INRC 2017) – for Tier 1 (randomised comparison)","definition_or_measurement_approach":"Progression-Free Survival measured as per INRC 2017 criteria for Tier 1 randomised comparison."}
  • {"endpoint_text":"- Definition of a safe and tolerable combination regimen – for Tier 2 (dose expansion-confirmation cohorts)","definition_or_measurement_approach":"Safety and tolerability assessed in dose expansion/confirmation cohorts (Tier 2) to define a safe/tolerable combination regimen."}

Secondary endpoints

  • {"endpoint_text":"- Best objective response (complete and partial response) as per INRC 2017 during trial treatment (12 cycles)","definition_or_measurement_approach":"Objective responses (complete, partial) assessed using INRC 2017 criteria during up to 12 cycles of trial treatment."}
  • {"endpoint_text":"- Clinical benefit (complete, partial and minor response and stable disease) as per INRC 2017.","definition_or_measurement_approach":"Clinical benefit determined per INRC 2017 including complete, partial, minor responses and stable disease."}
  • {"endpoint_text":"- Time response to progression (for responders)","definition_or_measurement_approach":"Time from response to documented progression for responders."}
  • {"endpoint_text":"- Overall Survival time","definition_or_measurement_approach":"Overall survival measured from randomisation/enrolment to death from any cause."}
  • {"endpoint_text":"- Quality of life measured by Peds-QL questionnaires","definition_or_measurement_approach":"Quality of life assessed using Peds-QL questionnaires."}
  • {"endpoint_text":"- Incidence and Severity of AEs","definition_or_measurement_approach":"Adverse events collected and graded to assess incidence and severity."}

Recruitment

Planned Sample Size
52
Recruitment Window Months
84
Consent Approach
Signed informed consent from participant, parent or guardian required. Age-specific consent/assent materials are provided (assent forms and ICFs for age groups such as 5-9, 8-11, 10-13, 12-15, 15-17, 16+, parent/guardian ICFs). Documents available in multiple country/language versions (examples in Spanish, Dutch, French, German, English (EN-GB), Swedish, Norwegian, Italian and country-specific versions listed in trial documents).

Geography

Total Number Of Sites
49
Total Number Of Participants
102

Spain

Earliest CTIS Part Ii Submission Date
02-07-2025
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
27
Number Of Sites
6
Number Of Participants
18

Sites

Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Pediatric Oncology
Contact Person Name
Mercedes Llempen
Site Name
Hospital Universitario La Paz
Department Name
Pediatric hematology-oncology and stem cell transplant
Contact Person Name
Pedro Rubio
Contact Person Email
pedro.rubio@salud.madrid.org
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Pediatric Oncology Unit
Contact Person Name
Adela Cañete
Contact Person Email
canyete_ade@gva.es
Site Name
Hospital Universitario De Cruces
Department Name
Pediatric Oncology and Hematology Section
Contact Person Name
Ricardo López Almara
Site Name
Hospital Universitari Vall D Hebron
Department Name
Paediatric Oncology and Hematology Unit
Contact Person Name
Lucas Moreno
Contact Person Email
lucas.moreno@vallhebron.cat
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Paediatric Haemato - Oncology Service
Contact Person Name
Alba Rubio
Contact Person Email
alba.rubio@salud.madrid.org

Netherlands

Earliest CTIS Part Ii Submission Date
04-07-2025
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
26
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Princess Maxima Center Utrecht
Department Name
Paediatric Oncology
Contact Person Name
Natasha Van Eijkelenburg

Austria

Earliest CTIS Part Ii Submission Date
19-06-2025
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
46
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
Johannes Kepler University Linz
Contact Person Name
Barbara Winkler
Site Name
Medizinische Universitaet Innsbruck
Contact Person Name
Roman Crazzolara
Contact Person Email
roman.crazzolara@i-med.ac.at
Site Name
St. Anna Kinderspital GmbH
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Heidrun Boztug
Contact Person Email
heidrun.boztug@stanna.at

Belgium

Earliest CTIS Part Ii Submission Date
08-07-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
20
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Department Name
Department of Pediatric Hemato-Oncology
Contact Person Name
Safiatou Diallo
Contact Person Email
Safiatou.diallo@hubruxelles.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Department of Pediatric Hemato-Oncology
Contact Person Name
Bénédicte Brichard
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Department of Pediatric Hemato-Oncology
Contact Person Name
Jaques Van Heerden
Contact Person Email
jaques.vanheerden@uza.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Department of Paediatric Haemato-oncology
Contact Person Name
Bram De Wilde
Contact Person Email
Bram.dewilde@uzgent.be
Site Name
UZ Leuven
Department Name
Department of Pediatric Hemato-Oncology
Contact Person Name
Marleen Renard
Contact Person Email
marleen.renard@uzleuven.be

Denmark

Earliest CTIS Part Ii Submission Date
09-07-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
19
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Rigshospitalet
Department Name
Department of Paediatric and Adolescent Medicine
Contact Person Name
Karsten Nysom
Contact Person Email
Karsten.nysom@regionh.dk

France

Earliest CTIS Part Ii Submission Date
23-07-2025
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
6
Number Of Sites
11
Number Of Participants
25

Sites

Site Name
Gustave Roussy
Department Name
Departement de Cancerologie de L’enfant et de L’adolescent
Contact Person Name
Pablo Berlanga
Site Name
Institut Curie
Department Name
Pédiatrie
Contact Person Name
Gudrun Schleiermacher
Contact Person Email
Gudrun.schleiermacher@curie.fr
Site Name
Centre Leon Berard
Department Name
Pediatric Oncology
Contact Person Name
Benoit Dumont
Contact Person Email
benoit.dumont@ihope.fr
Site Name
University Of Bordeaux
Department Name
Hémato Onco Ped
Contact Person Name
Julie Tandonnet
Site Name
ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
Contact Person Name
Carole Coze
Contact Person Email
carole.coze@ap-hm.fr
Site Name
CHRU De Nancy
Department Name
Service d’onco-hematologie pediatrique
Contact Person Name
Ludovic Mansuy
Contact Person Email
lu.mansuy@chru-nancy.fr
Site Name
CHU Nantes - HME-Department onco-hematology pédiatric
Contact Person Name
Estelle Thebaud
Contact Person Email
Estelle.THEBAUD@chu-nantes.fr
Site Name
Hopital Des Enfants
Department Name
Hematologie, immunologie et oncologie pédiatrique
Contact Person Name
Marion Gambart
Contact Person Email
gambart.m@chu-toulouse.fr
Site Name
Trousseau Hospital
Department Name
Hémato-immuno-oncologie
Contact Person Name
Hélène Boutroux
Contact Person Email
helene.boutroux@aphp.fr
Site Name
Centre Oscar Lambret
Department Name
Pediatric Oncology
Contact Person Name
Anne Sophie Defachelles Thomassin
Contact Person Email
AS-Defachelles@o-lambret.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Onco-hematologie-pediatrique
Contact Person Name
Sarah Jannier

Germany

Earliest CTIS Part Ii Submission Date
20-06-2025
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
39
Number Of Sites
11
Number Of Participants
24

Sites

Site Name
Universitätsklinikum Augsburg Schwäbisches Kinderkrebszentrum Kinderkrebsforschungszentrum Stenglins
Department Name
Universitätsklinikum Augsburg
Contact Person Name
Simone Storck
Contact Person Email
simone.storck@uk-augsburg.de
Site Name
Universitätsklinikum Köln Klinik und Poliklinik für Kinder- und Jugendmedizin Pädiatrische Onkologie
Department Name
Pädiatrische Onkologie und Hämatologie
Contact Person Name
Thorsten Simon
Contact Person Email
Thorsten.Simon@uk-koeln.de
Site Name
Universitätsmedizin der Johannes-Gutenberg-Universität Mainz
Department Name
Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Onkologie,
Contact Person Name
arthur Wingerter
Site Name
Universitätsklinikum Münster Klinik für Kinder- und Jugendmedizin, Pediatric Hematology/Oncology
Department Name
Pediatric Hematology/Oncology
Contact Person Name
Birgit Fröhlich
Contact Person Email
birgit.froehlich@ukmuenster.de
Site Name
Universitätsklinikum Essen
Department Name
Universitätsklinikum Essen
Contact Person Name
Uta Dirksen
Contact Person Email
uta.dirksen@uk-essen.de
Site Name
Ludwig Maximilian Universität München
Department Name
Ludwig Maximilian Universität München
Contact Person Name
Irene Schmid
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Pädiatric Hematology/Oncology Pädriatische Hematologie/Onkologie
Contact Person Name
Selim Corbacioglu
Contact Person Email
selim.corbacioglu@ukr.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Pediatric Oncology and Hematology
Contact Person Name
Hedwig Deubzer
Contact Person Email
hedwig.deubzer@charite.de
Site Name
Universitätsmedizin Greifswald Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Häm
Department Name
Pädiatrische Hämatologie und Onkologie
Contact Person Name
holger Lode
Site Name
Universitätsklinikum Hamburg-Eppendorf Poliklinik für Pädiatrische Hämatologie und Onkologie
Department Name
Universitätsklinikum Hamburg-Eppendorf,
Contact Person Name
Uwe Kordes
Contact Person Email
u.kordes@uke.de
Site Name
Universitätsklinikum Tübingen Klinik für Kinder- und Jugendmedizin
Department Name
Hämatologie und Onkologie
Contact Person Name
Tim Flaadt

Sweden

Earliest CTIS Part Ii Submission Date
17-06-2025
Latest Decision Or Authorization Date
01-08-2025
Processing Time Days
44
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Department Name
Child Oncologist
Contact Person Name
Torben Ek
Contact Person Email
Torben.ek@vgregion.se
Site Name
Astrid Lindgren Children´s Hospital, Karolinska University Hospital
Department Name
Child Oncologist
Contact Person Name
Kleopatra Georgantzi

Norway

Earliest CTIS Part Ii Submission Date
10-07-2025
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
19
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Pediatric Hematology and Oncology
Contact Person Name
Aina Ulvmoen
Contact Person Email
ainulv@ous-hf.no

Italy

Earliest CTIS Part Ii Submission Date
07-07-2025
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
23
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Ospedale Pediatrico Bambino Gesu
Department Name
Clinical Oncohematology and Cell Therapy Studies
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Aou Città Della Salute e Della Scienza di Torino
Contact Person Name
Franca Fagioli
Contact Person Email
fagioli@pediatria.unito.it
Site Name
Azienda Ospedaliera di Padova
Department Name
UOC Oncoematologia Pediatrica
Contact Person Name
Elisabetta Viscardi
Contact Person Email
elisabetta.viscardi@unipd.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Oncology and Hematology Department
Contact Person Name
Annalisa Tondo
Contact Person Email
annalisa.tondo@meyer.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S.C. Pediatria Oncologica
Contact Person Name
Roberto Luksch
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Dipartimento Emato-Oncologia
Contact Person Name
Carla Manzitti
Contact Person Email
carlamanzitti@gaslini.org
Site Name
Azienda Ospedaliera di Padova (additional entry present in list)

Sponsor

Primary sponsor

Full Name
The University Of Birmingham
Organisation Type
Educational Institution
Country Of Registered Address
United Kingdom

Contract research organisations

Name
Julius Clinical International B.V.
Responsibilities
sponsorDuties codes: 1
Name
Viedoc Technologies AB
Responsibilities
sponsorDuties codes: 7 (electronic data capture)

Third parties

  • {"country":"Belgium","full_name":"European Society for Paediatric Oncology","duties_or_roles":"code:4","organisation_type":"Health care"}
  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"code:1","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"France","full_name":"Mapi Research Trust","duties_or_roles":"code:15 (Quality of Life PedsQL)","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Recordati Pharmaceuticals Limited","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Orphelia Pharma","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Newcastle University","duties_or_roles":"code:4","organisation_type":"Educational Institution"}
  • {"country":"Sweden","full_name":"Viedoc Technologies AB","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Julius Clinical International B.V.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"St James's University Hospital","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Sweden","full_name":"ApoEx NKS","duties_or_roles":"code:14","organisation_type":"Health care"}

Investigational products

Investigational Product Name
TEMOZOLOMIDE
Active Substance
Temozolomide
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Investigational Product Name
BEVACIZUMAB
Active Substance
Bevacizumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Investigational Product Name
IRINOTECAN
Active Substance
Irinotecan
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
TOPOTECAN
Active Substance
Topotecan
Modality
Small molecule
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Investigational Product Name
Qarziba 4.5 mg/mL concentrate for solution for infusion
Active Substance
Dinutuximab beta
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS USE
Route
Intravenous
Authorisation Status
Authorised (marketing authorisation EU/1/17/1191/001)
Investigational Product Name
Kimozo 40 mg/ml, suspension buvable
Active Substance
Temozolomide
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised (marketing authorisation number 34009 589 035 7 1, authorisation country FR)
Orphan Designation
Yes
Combination Treatment
Yes

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