Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Фаза 1 – тестване на безопасността при малка група хора
Заболявания:
Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Спонсор: Amgen
Налично на:
БГ
Обобщение
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Кой може да участва
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.
Места на провеждане
12
Австралия (1)
Nepean Cancer Centre
Kingswood , New South Wales
Белгия (1)
Universite Catholique de Louvain Cliniques Universitaires Saint Luc