Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
In der Phase 2 der Studie soll geprüft werden, ob eine Behandlung mit oral verabreichtem AMG 510 wirksam, sicher und gut verträglich ist. Die Studie wird sich voraussichtlich über insgesamt etwa 4 Jahre erstrecken. Es wird damit gerechnet, dass insgesamt rund 200 Patienten an der Phase 2, der Studie teilnehmen werden.
Malattie studiate(Fonte di dati: BASEC)
Fortgeschrittene solide Tumoren mit KRAS-p.G12C-Mutation
Health conditions
(Fonte di dati: WHO)
KRAS p.G12C Mutant Advanced Solid Tumors
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
AMG 510 wird täglich als Tablette oral verabreicht. Die AMG 5210 Dosis, die in der Phase 2 verabreicht wird, wird in der Phase 1 bestimmt.
Interventions
(Fonte di dati: WHO)
Drug: sotorasib;Drug: Anti PD-1/L1;Drug: Midazolam
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Patienten mit einer pathologischen dokumentierten Diagnose von fortgeschrittenen soliden Tumoren mit einer KRAS p.G12C Mutation, sind für diese Studie geeignet.
Ausserdem müssen die Patienten für den Test auf die eine maximal 5 Jahre alte Tumorgewebeprobe zur Verfügung stellen bzw. sich vor Behandlungsbeginn einer Tumorbiopsie unterziehen.
Criteri di esclusione
(Fonte di dati: BASEC)
Patienten, die aktive Hirnmetastasen von Nichthirntumoren, anamnestisch bekannte oder aktuelle hämatologische Malignome aufweisen oder nicht in der Lage sind, Medikamente über den Mund einzunehmen, dürfen nicht an der Studie Teilnehmen
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: 100 Years
Minimum age: 18 Years
Inclusion Criteria:
- Men or women greater than or equal to 18 years old.
- Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C
mutation identified through molecular testing.
Exclusion Criteria
- Active brain metastases from non-brain tumors.
- Myocardial infarction within 6 months of study day 1.
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Active, not recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 1/Phase 2
Punti finali primari
(Fonte di dati: WHO)
Primary: Number of subjects with treatment-emergent adverse events;Primary: Number of subjects with treatment-related adverse events;Primary: Number of subjects with grade =3 treatment-emergent adverse events;Primary: Number of subjects with serious adverse events;Primary: Number of subjects with adverse events of interest;Primary: Number of subjects with clinically significant changes in vital signs;Primary: Number of subjects with clinically significant changes in physical examination results;Primary: Number of subjects with clinically significant changes on electrocardiograms (ECGs);Primary: Number of subjects with clinically significant changes in clinical laboratory values;Primary: Number of subjects with dose-limiting toxicities (DLTs);Primary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria;Primary: Duration of response (DOR) as assessed by RECIST 1.1 criteria;Primary: Disease control as assessed by RECIST 1.1 criteria;Primary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria;Primary: Time to response (TTR) as assessed by RECIST 1.1 criteria
Punti finali secondari
(Fonte di dati: WHO)
Secondary: Plasma concentration (Cmax) of sotorasib;Secondary: Plasma concentration (Cmax) of midazolam;Secondary: Time to achieve Cmax (Tmax) of sotorasib;Secondary: Area under the plasma concentration-time curve (AUC) of sotorasib;Secondary: Area under the plasma concentration-time curve (AUC) of midazolam;Secondary: Clearance of midazolam from the plasma;Secondary: Terminal half-life (t1/2) of midazolam;Secondary: Objective response rate (ORR) as assessed by RECIST 1.1 criteria;Secondary: Duration of response (DOR) as assessed by RECIST 1.1 criteria;Secondary: Disease control as assessed by RECIST 1.1 criteria;Secondary: Progression-free survival (PFS) as assessed by RECIST 1.1 criteria;Secondary: Duration of stable disease (SD) as assessed by RECIST 1.1 criteria;Secondary: Depth of response (best percentage change from baseline in lesion sum diameters) as assessed by RECIST 1.1 criteria;Secondary: Time to response (TTR) as assessed by RECIST 1.1 criteria;Secondary: Overall survival (OS);Secondary: sotorasib exposure and QTc interval relationship;Secondary: Progression-free survival (PFS) at 6 months;Secondary: Progression-free survival (PFS) at 12 months;Secondary: Overall survival (OS) at 12 months;Secondary: Number of subjects with treatment-emergent adverse events;Secondary: Number of subjects with grade =3 treatment-emergent adverse events;Secondary: Impact of treatment on disease-related symptoms and health related quality of life (HRQOL) as assessed by EORTC QLQ-C30;Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by disease-specific modules Quality-of-Life Questionnaire Lung Cancer Module (QLQ LC13);Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by non-small cell lung cancer symptom assessment questionnaire (NSCLC SAQ) for NSCLC;Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Severity (PGIS);Secondary: Impact of treatment on disease-related symptoms and HRQOL as assessed by Patient Global Impression of Change (PGIC) in cough, dyspnea and chest pain for NSCLC;Secondary: Treatment-related symptoms and impact on the subject as assessed by EORTC QLQ-C30;Secondary: Treatment-related symptoms and impact on the subject as assessed by selected questions from the Patient-reported Outcome of the Common Terminology Criteria for Adverse Events (PRO-CTCAE library);Secondary: Treatment-related symptoms and impact on the subject as assessed by a single item about symptom bother, item GP5 of the Functional Assessment of Cancer Therapy - General (FACT-G);Secondary: Change from baseline in physical function as assessed by EORTC QLQ-C30
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
Collegamento ai risultati nel registro primario
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)
Basilea, Ginevra, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Japan, Korea, Portugal, Republic of, Romania, Spain, Switzerland, United States
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr. med. Ulrich Richter
+41 43 253 22 65
ulrich.richter@usz.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
MD
Amgen
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
MD
Amgen
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
17.09.2021
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2019-01119
Secondary ID (Fonte di dati: WHO)
20170543
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