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Active (not recruiting) Phase 1 NCT04185883

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Phase 1 – testing safety in a small group of people
Conditions: Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Sponsor: Amgen

trial.available_in: БГ
Overview
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Who can participate
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 performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Exclusion Criteria: * Primary brain tumor. * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. * Myocardial infarction within 6 months of study day 1. * Gastrointestinal (GI) tract disease causing the inability to take oral medication.
Locations 12
Australia (1)
Nepean Cancer Centre
Kingswood , New South Wales
Belgium (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels
Canada (1)
CHU de Quebec Hopital de l Enfant Jesus
Québec , Quebec
Germany (1)
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin
Italy (1)
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan
Japan (1)
Aichi Cancer Center
Nagoya , Aichi-ken
Netherlands (1)
Universitair Medisch Centrum Utrecht
Utrecht
South Korea (1)
Seoul National University Hospital
Seoul
Spain (1)
Hospital Universitari Vall d Hebron
Barcelona , Catalonia
Taiwan (1)
National Cheng Kung University Hospital
Tainan
United Kingdom (1)
Sarah Cannon Research Institute UK
London
United States (1)
Arizona Oncology Associates Professional Corporation
Tucson , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
17.12.2019
Completion date
05.12.2027
Registry ID
NCT04185883
Source
anzctr
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