Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
In dieser klinischen Forschungsstudie wird untersucht, ob die Studienmedikamente Dabrafenib in Kombination mit Trametinib bei Kindern und Jugendlichen, die an BRAF V600-Mutation-positiven Gliomen leiden, wirksam und sicher sind. An dieser Studie werden weltweit voraussichtlich 102 Patienten mit tiefgradigem Gliom und 40 Patienten mit hochgradigem Gliom teilnehmen.
Patienten mit hochgradigem Gliom erhalten die Studienmedikamente Dabrafenib und Trametinib.
Patienten mit tiefgradigem Gliom werden per Zufall einer von zwei Behandlungsgruppen zugeteilt. 68 Patienten werden die Studienbehandlung mit Dabrafenib und Trametinib erhalten. 34 Patienten werden zum Vergleich die für diese Erkrankung übliche Standard-Chemotherapie mit Carboplatin und Vincristin erhalten. Ist die Behandlung mit der Chemotherapie nicht erfolgreich, ist ein Wechsel in die Dabrafenib & Trametinib Behandlungsgruppe unter gewissen Voraussetzungen möglich.
Die Studienteilnehmer erhalten die Studienbehandlung so lange, wie sie nach Ansicht des zuständigen Studienarztes eine positive Wirkung hat.
Malattie studiate(Fonte di dati: BASEC)
Kinder oder Jugendliche mit zwei Formen von Hirntumoren können an dieser Studie teilnehmen:
- Patienten mit einem BRAF V600-Mutation-positiven, refraktären oder rezidivierten, hochgradigen Gliom
- Patienten mit einem BRAF V600-Mutation-positiven tiefgradigen Gliom
Health conditions
(Fonte di dati: WHO)
Diffuse Astrocytoma;Anaplastic Astrocytoma;Astrocytoma;Oligodendroglioma, Childhood;Anaplastic Oligodendroglioma;Glioblastoma;Pilocytic Astrocytoma;Giant Cell Astrocytoma;Pleomorphic Xanthoastrocytoma;Anaplastic Pleomorphic Xanthoastrocytoma;Angiocentric Glioma;Chordoid Glioma of Third Ventricle;Gangliocytoma;Ganglioglioma;Anaplastic Ganglioglioma;Dysplastic Gangliocytoma of Cerebrellum;Desmoplastic Infantile Astrocytoma and Ganglioglioma;Papillary Glioneuronal Tumor;Rosette-forming Glioneurona Tumor;Central Neurocytoma;Extraventricular Neurocytoma;Cerebellar Iponeurocytoma
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Patienten in der Dabrafenib & Trametinib Behandlungsgruppe: Dabrafenib wird zweimal pro Tag und Trametinib einmal pro Tag eingenommen.
Patienten in der Chemotherapie Behandlungsgruppe. Die Chemotherapie wird gemäss der lokal üblichen Praxis per Infusion verabreicht (In der Regel wöchentlich, mit Unterbrüchen).
Während der Studienbehandlung wird der Gesundheitszustand der Studienteilnehmer regelmässig kontrolliert. Im ersten Behandlungsjahr wird die Grösse des Tumors mittels bildgebenden Untersuchungen (MRT des Gehirns) alle 8 Wochen gemessen. Danach sind MRT Untersuchungen alle 16 Wochen vorgesehen.
Interventions
(Fonte di dati: WHO)
Drug: Dabrafenib;Drug: trametinib;Drug: Carboplatin;Drug: Vincristine
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
- Kinder und Jugendliche im Alter zwischen 12 Monaten und 17 Jahren
- Histologisch (durch Analyse des Tumorgewebes unter dem Mikroskop) bestätigte Diagnose eines hochgradigen bzw. tiefgradigen Glioms
- Vorliegen einer sogenannte BRAF V600-Mutation im Tumorgewebe
Criteri di esclusione
(Fonte di dati: BASEC)
- Vorliegen anderer Krebserkrankungen als ein BRAF-Mutation-positives Gliom
- Vorangehende Behandlung mit Dabrafenib (oder einem anderen RAF-Inhibitor), Trametinib (oder einem anderen MEK-Inhibitor) oder einem ERK-Inhibitor.
-Bei hochgradigem Gliom: Andere Krebstherapien während den 3 vorhergehenden Wochen vor dem Start der Studienbehandlung
-Bei tiefgradigem Gliom: Andere vorausgehende systemische, medikamentöse Krebstherapien
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: 17 Years
Minimum age: 12 Months
Key Inclusion Criteria:
- Diagnosis of BRAF V600 mutant High Grade glioma that had relapsed, progressed or
failed to respond to frontline therapy
- Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following
surgical excision, or non-surgical candidates with necessity to begin first systemic
treatment because of a risk of neurological impairment with progression.
- Confirmed measurable disease
Key Exclusion Criteria:
- Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK
inhibitor
- HGG patient: Cancer treatment within the past 3 weeks. LGG patient: Any systemic
therapy or radiotherapy prior to enrollment
- LGG patients: history of allergic reaction or contraindications to the use of
carboplatin or vincristine
- Stem cell transplant within the past 3 months
- History of heart disease
- Pregnant or lactating females
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Phase II Open-label Global Study to Evaluate the Effect of Dabrafenib in Combination With Trametinib in Children and Adolescent Patients With BRAF V600 Mutation Positive Low Grade Glioma (LGG) or Relapsed or Refractory High Grade Glioma (HGG)
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 2
Punti finali primari
(Fonte di dati: WHO)
LGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using Response Assessment in Neuro-Oncology (RANO) Criteria;HGG Cohort: Overall Response Rate (ORR) by Central Independent Assessment Using RANO Criteria
Punti finali secondari
(Fonte di dati: WHO)
HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension and Trametinib Oral Solution Based on the Palatability Questionnaire Item: Reaction Once the Medication Was Immediately Placed Into the Mouth;HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension and Trametinib Oral Solution Based on the Palatability Questionnaire Item: After Taste Once Rinsing the Mouth With Water Remained;LGG Cohort: Parent Proxy Global Health 7+2 Scores- Global Health Score;LGG Cohort: Parent Proxy Global Health 7+2 Scores- Pain Score;LGG Cohort: Parent Proxy Global Health 7+2 Scores- Fatigue Score;LGG Cohort: ORR by Investigator Assessment Using RANO Criteria;LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria;LGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria;LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria;LGG Cohort: Kaplan-Meier Progression-Free Survival (PFS) as Per Investigator Assessment Using RANO Criteria;LGG Cohort: Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria;LGG Cohort: Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria;LGG Cohort: Clinical Benefit Rate (CBR) by Central Independent Assessment Using RANO Criteria;LGG Cohort: Clinical Benefit Rate (CBR) by Investigator Assessment Using RANO Criteria;LGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS);LGG Cohort: 2-year OS Estimate;HGG Cohort: ORR by Investigator Assessment Using RANO Criteria;HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Central Independent Assessment Using RANO Criteria;HGG Cohort: Kaplan-Meier Estimates of Duration of Response (DOR) as Per Investigator Assessment Using RANO Criteria;HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Central Independent Assessment Using RANO Criteria;HGG Cohort: Kaplan-Meier Estimates of Progression Free Survival (PFS) as Per Investigatort Assessment Using RANO Criteria;HGG Cohort: Time to Response (TTR) as Per Central Independent Assessment Using RANO Criteria;HGG Cohort: Time to Response (TTR) as Per Investigator Assessment Using RANO Criteria;HGG Cohort: Clinical Benefit Rate (CBR) as Per Central Independent Assessment Using RANO Criteria;HGG Cohort: Clinical Benefit Rate (CBR) as Per Investigator Assessment Using RANO Criteria;HGG Cohort: Kaplan-Meier Estimates of Overall Survival (OS);AUClast for Trametinib;Cmax for Trametinib;AUCtau for Trametinib;Tmax for Trametinib;T1/2 for Trametinib;Ctrough for Trametinib;AUClast for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);Cmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);AUCtau for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);Tmax for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);T1/2 for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);Ctrough for Dabrafenib and Its Metabolites (Carboxy-dabrafenib, Desmethyl-dabrafenib Amd Hydroxy-dabrafenib);HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension and Trametinib Oral Solution Based on the Palatability Questionnaire Item: Taste of the Medication Before Rinsing the Mouth;HGG and LGG Cohort: Palatability of Dabrafenib Oral Suspension and Trametinib Oral Solution Based on the Palatability Assessment: After- Taste Once the Medication Was Swallowed
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
ancora nessuna informazione disponibile
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Netherlands, Russian Federation, Spain, Sweden, Switzerland, United Kingdom, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Janine Landolt
+41 79 500 93 56
janine.landolt@novartis.com
Contatto per informazioni generali
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
26.10.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2017-01632
Secondary ID (Fonte di dati: WHO)
2015-004015-20
CDRB436G2201
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