Treatment of Solid Tumors Harboring KRAS Mutation With Imatinib and Trametinib

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
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• Patients will be included in the study if they meet all of the following criteria:

• Participants with age ≥ 20 years old.

• Histologically confirmed locally advanced or metastatic solid tumors with KRAS G12X mutation.

• Documented disease progression during or within 6 months after standard chemotherapies or no available standard therapy.

• Documented measurable disease as defined by RECIST v1.1.

• ECOG Performance Status 0-2.

• Participants has life expectancy of at least 8 weeks.

• Adequate hematologic parameters, and hepatic and renal functions defined as

∙ Hematological: white blood cell ≥3,000/ul, absolute neutrophil count (ANC) ≥1,500/ul, hemoglobin ≥9 g/dl and platelet count ≥ 90,000/ul.

‣ 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).

‣ Renal: serum creatinine level ≦2 x ULN or creatinine clearance ≥ 30 ml/min \[calculated by either Cockcroft-Gault equation \[(140-age) x body weight (kg) x (1 if male or 0.85 if female) / (72 x serum creatinine level, mg/dl)\] or 24-hour urine test\].

• Adequate blood coagulation function, defined as prothrombin time international normalized ratio (PT INR)≦ 2.3.

• Normal ECG or ECG without any clinical significant findings.

⁃ Able to understand and sign an informed consent (or have a legal representative who is able to do so).

⁃ Women or men of reproductive potential should agree to use an effective contraceptive method.

Locations
Other Locations
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Li-Yuan Bai
lybai6@gmail.com
+886-975-680-928
Time Frame
Start Date: 2025-05-10
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 10
Treatments
Experimental: Imatinib + Trametinib
1. Participants will receive oral imatinib 100 mg/day and trametinib 2 mg/day.~2. If there is no severe adverse event, the dose of imatinib could be increased to 200mg/day and the dose of trametinib reduced to 1 mg/day since cycle 2 per treating physician's judgement.~3. Four weeks of treatment is regarded as one cycle.
Sponsors
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov

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