Brief description of trial (Data source: 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.
Health conditions investigated(Data source: BASEC)
Fortgeschrittene solide Tumoren mit KRAS-p.G12C-Mutation
Health conditions
(Data source: WHO)
KRAS p.G12C Mutant Advanced Solid Tumors
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: 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
(Data source: WHO)
Drug: sotorasib;Drug: Anti PD-1/L1;Drug: Midazolam
Criteria for participation in trial
(Data source: 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.
Exclusion criteria
(Data source: 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
(Data source: 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.
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: 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)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 1/Phase 2
Primary end point
(Data source: 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
Secundary end point
(Data source: 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
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Geneva, Zurich
Countries
(Data source: WHO)
Australia, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Japan, Korea, Portugal, Republic of, Romania, Spain, Switzerland, United States
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. med. Ulrich Richter
+41 43 253 22 65
ulrich.richter@usz.ch
Contact for general information
(Data source: WHO)
MD
Amgen
Contact for scientific information
(Data source: WHO)
MD
Amgen
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
17.09.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01119
Secondary ID (Data source: WHO)
20170543
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