Actively Recruiting
Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations
Led by N.N. Petrov National Medical Research Center of Oncology · Updated on 2024-01-29
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
There is a huge variety of nucleotide substitutions that activate RAS. The search for new "universal" drugs for the RAS pathway that either interfere with RAS upregulation upstream in the signaling pathway or offset the consequences of RAS activation is important for improving therapeutic outcomes for patients with refractory malignancies. The use of leflunomide or the combination of MEK inhibitor + hydroxychloroquine ± bevacizumab is promising for patients with mutations in RAS cascade genes who have failed all existing treatment standards.
CONDITIONS
Official Title
Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent to participate
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Histologically confirmed metastatic stage 4 disease
- Documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years from tumor tissue
- Received more than 2 lines of standard anti-tumor drug therapy
- Disease progression according to RECIST version 1.1 criteria
- Adequate hematologic and liver function including:
- Absolute neutrophil count at least 1.5 x 10^9/L
- Lymphocyte count at least 0.5 x 10^9/L
- Platelet count at least 100 x 10^9/L without transfusion
- Hemoglobin at least 90 g/L without transfusion
- Creatinine clearance at least 40 mL/min
- Serum albumin at least 25 g/L
- Serum bilirubin at most 1.5 times normal, or up to 3 times normal for patients with Gilbert's disease or liver metastases
- AST, ALT, and alkaline phosphatase at most 2.5 times normal
- For women of childbearing potential: agree to abstain from heterosexual intercourse or use two effective contraception methods during treatment
- Patients with asymptomatic new or advanced brain metastases eligible if no localized treatment needed by physician
You will not qualify if you...
- Older than 85 years
- Presence of acute or active chronic infections
- Impaired kidney or liver function or left ventricular ejection fraction below 45%
- History of acute or chronic hepatitis B or C
- Allergic reactions to leflunomide, teriflunomide, or similar drugs
- Uncontrolled diseases such as active infection, symptomatic heart failure, unstable angina, arrhythmias, or mental health/social issues limiting study compliance
- Pregnant or breastfeeding women
- History of retinal diseases or current risk factors for retinal problems such as glaucoma or hypercoagulability syndromes
- Refusal to continue study participation
- Intolerable toxicity
- Disease progression requiring change in treatment
- Non-compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology, Saint Petersburg, Russian Federation
Saint Petersburg, Russia
Actively Recruiting
Research Team
E
Evgeny Imyanitov
CONTACT
L
Liliya Baboshkina
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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