Clinical trial • Phase III • Oncology
DINUTUXIMAB BETA for Low-risk neuroblastoma | Intermediate-risk neuroblastoma
Phase III trial of DINUTUXIMAB BETA for Low-risk neuroblastoma | Intermediate-risk neuroblastoma. 280 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Low-risk neuroblastoma | Intermediate-risk neuroblastoma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule|Peptide/protein/enzyme
- Paediatric Trial
- Yes
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 04-10-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
Phase III trial in Germany.
- Biomarker Stratified
- True, RNA expression (gene expression) classifier
- Target Sample Size
- 280
Eligibility
Recruits 280 paediatric patients.
- Pregnancy Exclusion
- Pregnancy or lactation
- Vulnerable Population
- Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development. Subject information and informed consent forms available for adults, adolescents, custodial guardians and children (documents listed: L1_SIS and ICF adults_p; L1_SIS and ICF adolescent_p; L1_SIS and PIC custodial_p; L1_SIS and PIC child).
Inclusion criteria
- {"criterion_text":"- Neuroblastoma diagnosed according to the accepted criteria: histological diagnosis from tumor tissue or presence of distinct neuroblastoma cells in the bone marrow and elevated catecholamine metabolites (HVA, VMA) in blood or urine\n- MYCN not amplified\n- Stage and age either: a. localized neuroblastoma INRGSS stage L1/L2/INSS stage 1-3 and age at diagnosis ≥18 months and < 21 years b. INSS Stage 4S/INRGSS stage MS c. INSS Stage 4/INRGSS stage M and age at diagnosis <18 months d. INRGSS stage L1/L2 and age at first diagnosis <18 months with relapse or progression of neuroblastoma\n- Sufficient tumor tissue available from initial diagnosis available for analysis of RNA expression array\n- Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development"}
Exclusion criteria
- {"criterion_text":"- Participation in other clinical trials\n- History of earlier VOD/SOS of the liver\n- Impaired bone marrow function defined by granulocytes <500/μl and/or thrombocytes <50.000/μl unless clearly caused by bone marrow involvement proven by bone marrow cytology or diffuse abnormal osteomedullary signal in the mIBG scintigraphy\n- HIV infection because of the antiretroviral medication which potentially interferes with the metabolism of the scheduled investigational drugs\n- Pregnancy or lactation\n- Insufficient contraception for sexually active study participants as well as female partners of sexually active male trial participants. Patients must be informed about the need of adequate contraception. Moreover, this need for contraception must be understood by the trial participants. Only contraception with a Pearl index <1% are considered as sufficient. For the purpose of this trial, these are long-term parenteral hormones, progesterone releasing implants, intramuscular progesterone, and intrauterine hormone releasing devices, tubal ligation, and vaginal hormonal contraception. This also holds true for adolescents who are at risk to become sexually active during trial participation\n- Any concomitant non-protocol anticancer therapy\n- Incomplete initial staging\n- Known allergy/hypersensitivity to the scheduled drugs\n- Impaired cardiac function such as insufficiency, heart rate abnormalities and blood pressure abnormalities corresponding to CTCAE 5.0 grade 2 or higher. Hypertension according to age specific reference values clearly due to neuroblastoma is no exclusion criterion\n- Impaired renal function defined by a reduced glomerular filtration rate <30 ml/min*1,73 m2 determined by serum creatinine (Schwartz formula) or serum cystatin C\n- Impaired liver function corresponding to CTCAE 5.0 grade 3 or higher unless liver impairment is clearly caused by neuroblastoma in stage 4S/MS patients. Isolated elevation of the transaminases without evidence of impaired liver function is not an exclusion criterion"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event-free survival (EFS): Time from diagnosis to event or last follow-up for patients without event; event is defined as death for all reasons, progression and relapse following previous complete remission or secondary malignant disease","definition_or_measurement_approach":"Time from diagnosis to event or last follow-up; event defined as death for all reasons, progression, relapse after prior complete remission, or secondary malignant disease."}
Secondary endpoints
- {"endpoint_text":"- Overall Survival (OS): Because of the importance for the individual patient OS has been chosen as secondary endpoint.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Risk factors to impact on EFS and OS: The risk factors age at diagnosis, stage according to INSS and INRG, and copy number alterations of selected genes have been implemented in the INRG classification. These factors will be assessed by multivariate and subgroup analysis. Moreover, the description of patients’ cohorts by these risk factors is mandatory for international comparison of the trial results.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Response: In neuroblastoma, response to trial treatment is not clearly correlated to outcome. In this trial, response to trial treatment will be compared to historical controls, with a special focus to the cohort with reduced treatment (group C).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Regression: The percentage of spontaneous regression will be described in patients where the residual primary is observed without cytotoxic treatment and compared to historical controls.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Incidence rates of toxic events: The administered chemotherapy cycles are known to cause treatment related side effects. To estimate the burden for the patients, kind and intensity of side effects will be compared to historical controls and between the patient groups A-C.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Additional molecular analysis: The impact of clinical and molecular risk factors such as copy number alterations, telomere maintenance status and mutation status of candidate genes on EFS and OS will be analyzed.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Group D, relapsed patients: Outcome of patients with relapse or progression of neuroblastoma diagnosed at the age < 18 months with unfavorable classification.","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 280
- Recruitment Window Months
- 132
- Consent Approach
- Guardians’ informed consent and/ or patient’s informed consent if appropriate according to age and status of psycho-intellectual development. Subject information and informed consent forms are provided for adults, adolescents, custodial guardians and children (documents listed in CTIS: L1_SIS and ICF adults_p; L1_SIS and ICF adolescent_p; L1_SIS and PIC custodial_p; L1_SIS and PIC child).
Geography
- Total Number Of Sites
- 29
- Total Number Of Participants
- 280
Germany
- Earliest CTIS Part Ii Submission Date
- 17-10-2024
- Latest Decision Or Authorization Date
- 25-10-2024
- Processing Time Days
- 8
- Number Of Sites
- 29
- Number Of Participants
- 280
Sites
- Site Name
- Asklepios Klinik Sankt Augustin GmbH
- Department Name
- Pädiatrische Onkologie und Hämatologie
- Principal Investigator Name
- Harald Reinhard
- Principal Investigator Email
- h.reinhard@asklepios.com
- Contact Person Name
- Harald Reinhard
- Contact Person Email
- h.reinhard@asklepios.com
- Site Name
- HELIOS Klinikum Erfurt GmbH
- Department Name
- Klinik für Kinder- und Jugendmedizin, Päd. Hämatologie und Onkologie
- Principal Investigator Name
- Axel Sauerbrey
- Principal Investigator Email
- axel.sauerbrey@helios-gesundheit.de
- Contact Person Name
- Axel Sauerbrey
- Contact Person Email
- axel.sauerbrey@helios-gesundheit.de
- Site Name
- Gesundheit Nord gGmbH Klinikverbund Bremen
- Department Name
- Klinikum Bremen-Mitte, Eltern-Kind-Zentrum Prof. Hess, Kinderonkologie-Station 3
- Principal Investigator Name
- Arnulf Pekrun
- Principal Investigator Email
- arnulf.pekrun@klinikum-bremen-mitte.de
- Contact Person Name
- Arnulf Pekrun
- Contact Person Email
- arnulf.pekrun@klinikum-bremen-mitte.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Päd. Hämatologie, Onkologie u. SZT
- Principal Investigator Name
- Udo Kontny
- Principal Investigator Email
- ukontny@ukaachen.de
- Contact Person Name
- Udo Kontny
- Contact Person Email
- ukontny@ukaachen.de
- Site Name
- Evangelisches Klinikum Bethel gGmbH
- Department Name
- Campus Bielefeld-Bethel, Hämatologie/Onkologie
- Principal Investigator Name
- Norbert Jorch
- Principal Investigator Email
- norbert.jorch@evkb.de
- Contact Person Name
- Norbert Jorch
- Contact Person Email
- norbert.jorch@evkb.de
- Site Name
- Universitaetsklinikum Giessen und Marburg GmbH
- Department Name
- Pediatric Hematology, Oncology & Immunodeficiencies
- Principal Investigator Name
- Christine Mauz-Körholz
- Principal Investigator Email
- christine.mauz-koerholz@paediat.med.uni-giessen.de
- Contact Person Name
- Christine Mauz-Körholz
- Contact Person Email
- christine.mauz-koerholz@paediat.med.uni-giessen.de
- Site Name
- Universitaet Leipzig
- Department Name
- Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
- Principal Investigator Name
- Hagen Graf Einsiedel
- Principal Investigator Email
- hagen.grafeinsiedel@medizin.uni-leipzig.de
- Contact Person Name
- Hagen Graf Einsiedel
- Contact Person Email
- hagen.grafeinsiedel@medizin.uni-leipzig.de
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Clinic for Pediatric and Adolescent Medicine, Pediatric Hematology and Oncology
- Principal Investigator Name
- Christof Kramm
- Principal Investigator Email
- christof.kramm@med.uni-goettingen.de
- Contact Person Name
- Christof Kramm
- Contact Person Email
- christof.kramm@med.uni-goettingen.de
- Site Name
- Klinikum Dortmund gGmbH
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Dominik Schneider
- Principal Investigator Email
- dominik.schneider@klinikumdo.de
- Contact Person Name
- Dominik Schneider
- Contact Person Email
- dominik.schneider@klinikumdo.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
- Principal Investigator Name
- Theresa Thole
- Principal Investigator Email
- theresa.thole@charite.de
- Contact Person Name
- Theresa Thole
- Contact Person Email
- theresa.thole@charite.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Pediatric Oncology
- Principal Investigator Name
- Thorsten Simon
- Principal Investigator Email
- thorsten.simon@uk-koeln.de
- Contact Person Name
- Thorsten Simon
- Contact Person Email
- thorsten.simon@uk-koeln.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- Klinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie
- Principal Investigator Name
- Mária Praženicová
- Principal Investigator Email
- maria.prazenicova@ukdd.de
- Contact Person Name
- Mária Praženicová
- Contact Person Email
- maria.prazenicova@ukdd.de
- Site Name
- Otto Von Guericke Universitaet Magdeburg
- Department Name
- Abt. Pädiatrische Hämatologie und Onkologie
- Principal Investigator Name
- Antje Redlich
- Principal Investigator Email
- antje.redlich@med.ovgu.de
- Contact Person Name
- Antje Redlich
- Contact Person Email
- antje.redlich@med.ovgu.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Dept. of Paediatric Haematology, Oncology and Stem Cell Transplantation
- Principal Investigator Name
- Marcus Jakob
- Principal Investigator Email
- marcus.jakob@ukr.de
- Contact Person Name
- Marcus Jakob
- Contact Person Email
- marcus.jakob@ukr.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Klinik und Poliklinik für Kinder- und Jugendmedizin Kinderonkologisches Zentrum
- Principal Investigator Name
- Jörg Faber
- Principal Investigator Email
- faber@uni-mainz.de
- Contact Person Name
- Jörg Faber
- Contact Person Email
- faber@uni-mainz.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Zentrum für Kinder- und Jugendmedizin Abt. Päd. Hämatologie/Onkologie
- Principal Investigator Name
- Dagmar Dilloo
- Principal Investigator Email
- dagmar.dilloo@ukbonn.de
- Contact Person Name
- Dagmar Dilloo
- Contact Person Email
- dagmar.dilloo@ukbonn.de
- Site Name
- HELIOS Klinikum Berlin-Buch GmbH
- Department Name
- Klinik für Kinder- und Jugendmedizin, Päd. Onkologie/Hämatologie
- Principal Investigator Name
- Patrick Hundsdörfer
- Principal Investigator Email
- Patrick.Hundsdoerfer@helios-gesundheit.de
- Contact Person Name
- Patrick Hundsdörfer
- Contact Person Email
- Patrick.Hundsdoerfer@helios-gesundheit.de
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- Kinderkrankenhaus
- Principal Investigator Name
- Meinolf Siepermann
- Principal Investigator Email
- siepermannm@kliniken-koeln.de
- Contact Person Name
- Meinolf Siepermann
- Contact Person Email
- siepermannm@kliniken-koeln.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Kinder- und Jugendklinik, Abteilung für Päd. Onkologie und Hämatologie
- Principal Investigator Name
- Markus Metzler
- Principal Investigator Email
- markus.metzler@uk-erlangen.de
- Contact Person Name
- Markus Metzler
- Contact Person Email
- markus.metzler@uk-erlangen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Universitätskinderklinik, Hämatologie und Onkologie
- Principal Investigator Name
- Paul Gerhardt Schlegel
- Principal Investigator Email
- schlegel_p@ukw.de
- Contact Person Name
- Paul Gerhardt Schlegel
- Contact Person Email
- schlegel_p@ukw.de
- Site Name
- Klinikum Der Landeshauptstadt Stuttgart gKAöR
- Department Name
- Pädiatrie 5 (Onkologie, Hämatologie, Immunologie)
- Principal Investigator Name
- Claudia Blattmann
- Principal Investigator Email
- c.blattmann@klinikum-stuttgart.de
- Contact Person Name
- Claudia Blattmann
- Contact Person Email
- c.blattmann@klinikum-stuttgart.de
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Klinik für Kinder- und Jugendmedizin
- Principal Investigator Name
- Bernd Gruhn
- Principal Investigator Email
- bernd.gruhn@med.uni-jena.de
- Contact Person Name
- Bernd Gruhn
- Contact Person Email
- bernd.gruhn@med.uni-jena.de
- Site Name
- Klinikum Kassel GmbH
- Department Name
- Klinik für päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen
- Principal Investigator Name
- Michaela Nathrath
- Principal Investigator Email
- michaela.nathrath@klinikum-kassel.de
- Contact Person Name
- Michaela Nathrath
- Contact Person Email
- michaela.nathrath@klinikum-kassel.de
- Site Name
- Universitaet Muenster
- Department Name
- Klinik für Kinder- und Jugendmedizin Paediatrische Haematology and Onkologie
- Principal Investigator Name
- Birgit Fröhlich
- Principal Investigator Email
- birgit.froehlich@ukmuenster.de
- Contact Person Name
- Birgit Fröhlich
- Contact Person Email
- birgit.froehlich@ukmuenster.de
- Site Name
- Staedtisches Klinikum Karlsruhe gGmbH
- Department Name
- Franz Lust Kinderklinik Pädiatrische Hämatologie und Onkologie
- Principal Investigator Name
- Alfred Leipold
- Principal Investigator Email
- alfred.leipold@klinikum-karlsruhe.de
- Contact Person Name
- Alfred Leipold
- Contact Person Email
- alfred.leipold@klinikum-karlsruhe.de
- Site Name
- HELIOS Klinikum Krefeld GmbH
- Department Name
- Zentrum für Kinder- und Jugendmedizin Abt. für Hämatologie und Onkologie
- Principal Investigator Name
- Thomas Imschweiler
- Principal Investigator Email
- thomas.imschweiler@helios-gesundheit.de
- Contact Person Name
- Thomas Imschweiler
- Contact Person Email
- thomas.imschweiler@helios-gesundheit.de
- Site Name
- Universitaetsklinikum Augsburg
- Department Name
- Klinik für Kinder- und Jugendmedizin Schwäbisches Kinderkrebszentrum
- Principal Investigator Name
- Michael Frühwald
- Principal Investigator Email
- michael.fruehwald@uk-augsburg.de
- Contact Person Name
- Michael Frühwald
- Contact Person Email
- michael.fruehwald@uk-augsburg.de
- Site Name
- Universitaetsklinikum Mannheim GmbH
- Department Name
- Kinderonkologie
- Principal Investigator Name
- Matthias Dürken
- Principal Investigator Email
- matthias.duerken@umm.de
- Contact Person Name
- Matthias Dürken
- Contact Person Email
- matthias.duerken@umm.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Klinik Pädiatrie I für Pädiatrische Onkologie, Hämatologie, Rheumatologie und Immunologie
- Principal Investigator Name
- Toralf Bernig
- Principal Investigator Email
- toralf.bernig@uk-halle.de
- Contact Person Name
- Toralf Bernig
- Contact Person Email
- toralf.bernig@uk-halle.de
Sponsor
Primary sponsor
- Full Name
- University Of Cologne
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Germany
Third parties
- {"country":"Germany","full_name":"Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts","duties_or_roles":"Bioinformatic analysis (“NB-profiler software”)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Prinses Maxima Centrum voor Kinderoncologie B.V.","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"RNA microarray analysis (\"NB profiler wet lab\")","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Central review of bone marrow cytology and immunocytology","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Universitaetsklinikum Tuebingen AöR","duties_or_roles":"Reference assessment medical imaging","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Routine clinical pathology testing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Reference assessment medical imaging (nuclear medicine)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"University Hospital Cologne AöR","duties_or_roles":"Central review of bone marrow cytology and immunocytology","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Charite Universitaetsmedizin Berlin KöR","duties_or_roles":"Reference assessment medical imaging (nuclear medicine)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Universitaetsklinikum Bonn AöR","duties_or_roles":"Central review for pathology testing","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Germany","full_name":"Universitaet Muenster","duties_or_roles":"","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- DINUTUXIMAB BETA
- Active Substance
- DINUTUXIMAB BETA
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Orphan Designation
- Yes
- Maximum Dose
- 5000 mg/m2 milligram(s)/square meter
- Investigational Product Name
- CISPLATIN
- Active Substance
- CISPLATIN
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 480 mg/m2 milligram(s)/square meter
- Investigational Product Name
- MELPHALAN
- Active Substance
- MELPHALAN
- Modality
- Small molecule
- Routes Of Administration
- POWDER AND SOLVENT FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 140 mg/m2 milligram(s)/square meter
- Investigational Product Name
- FILGRASTIM
- Active Substance
- FILGRASTIM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION / SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Maximum Dose
- 400 µg/Kg microgram(s)/kilogram
- Investigational Product Name
- VINDESINE SULFATE
- Active Substance
- VINDESINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- POWDER FOR SOLUTION FOR INJECTION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 9 mg/m2 milligram(s)/square meter
- Investigational Product Name
- VINCRISTINE SULFATE
- Active Substance
- VINCRISTINE SULFATE
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION/INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 9 mg/m2 milligram(s)/square meter
- Investigational Product Name
- CLONAZEPAM
- Active Substance
- CLONAZEPAM
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INJECTION/INFUSION (intravenous)
- Route
- INTRAVENOUS
- Maximum Dose
- 0.7 mg/kg milligram(s)/kilogram
- Investigational Product Name
- BUSULFAN
- Active Substance
- BUSULFAN
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 19.2 mg/kg milligram(s)/kilogram
- Investigational Product Name
- CYCLOPHOSPHAMIDE (COATED TABLET)
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- COATED TABLET (ORAL)
- Route
- ORAL
- Maximum Dose
- 4800 mg/m2 milligram(s)/square meter
- Investigational Product Name
- ETOPOSIDE
- Active Substance
- ETOPOSIDE
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 1200 mg/m2 milligram(s)/square meter
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 640 mg/m2 milligram(s)/square meter
- Investigational Product Name
- CYCLOPHOSPHAMIDE (POWDER FOR SOLUTION FOR INFUSION)
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- POWDER FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 8400 mg/m2 milligram(s)/square meter
- Investigational Product Name
- LENOGRASTIM
- Active Substance
- LENOGRASTIM
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION (SUBCUTANEOUS INJECTION)
- Route
- SUBCUTANEOUS INJECTION
- Maximum Dose
- 400 µg/Kg microgram(s)/kilogram
- Investigational Product Name
- MESNA
- Active Substance
- MESNA
- Modality
- Small molecule
- Routes Of Administration
- SOLUTION FOR INJECTION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 18900 mg/m2 milligram(s)/square meter
- Investigational Product Name
- DOXORUBICIN HYDROCHLORIDE
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- CONCENTRATE FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 180 mg/m2 milligram(s)/square meter
- Investigational Product Name
- ETOPOSIDE PHOSPHATE
- Active Substance
- ETOPOSIDE PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- POWDER FOR SOLUTION FOR INJECTION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 1200 mg/m2 milligram(s)/square meter
- Investigational Product Name
- DACARBAZINE
- Active Substance
- DACARBAZINE
- Modality
- Small molecule
- Routes Of Administration
- POWDER FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 3000 mg/m2 milligram(s)/square meter
- Investigational Product Name
- IFOSFAMIDE
- Active Substance
- IFOSFAMIDE
- Modality
- Small molecule
- Routes Of Administration
- POWDER FOR SOLUTION FOR INFUSION (intravenous infusion)
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 22500 mg/m2 milligram(s)/square meter
- Combination Treatment
- Yes
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- Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)