Imatinib and Trametinib for KRAS-mutated Solid Tumor
Trial Parameters
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Brief Summary
In this pilot trial, participants with unresectable solid cancers harboring KRAS mutations will be provided with a compassionate treatment if their diseases progress after current standard treatments, or there is no available standard treatment. This trial will evaluate the efficacy and safety of the combination of trametinib and imatinib on chemotherapy refractory solid cancers.
Eligibility Criteria
Inclusion criteria: Patients will be included in the study if they meet all of the following criteria: 1. Participants with age ≥ 20 years old. 2. Histologically confirmed locally advanced or metastatic solid tumors with KRAS G12X mutation. 3. Documented disease progression during or within 6 months after standard chemotherapies or no available standard therapy. 4. Documented measurable disease as defined by RECIST v1.1. 5. ECOG Performance Status 0-2. 6. Participants has life expectancy of at least 8 weeks. 7. Adequate hematologic parameters, and hepatic and renal functions defined as 1. Hematological: white blood cell ≥3,000/ul, absolute neutrophil count (ANC) ≥1,500/ul, hemoglobin ≥9 g/dl and platelet count ≥ 90,000/ul. 2. Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥2.5 x upper limit of normal (ULN) (≥5.0 x ULN if attributable to liver metastases), and total bilirubin ≥1.5 x upper limit of normal (ULN) (≥3.0 x ULN if attributable to liver metastases