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New treatment option for RAS Mutation
Official title Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations
ClinicalTrials.gov ID: NCT06229340
What this study is testing
What is Leflunomide?
Leflunomide is an investigational medicine, given as an once-daily, being studied as a potential treatment for ras mutation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Patient is able to provide informed consent and sign approved consent forms to participate in the study.
- Patient age is at least 18 years old.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
- Histologically confirmed metastatic metastatic disease stage 4.
- Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.
You likely can't join if
- Age over 85 years.
- Рresence of acute or active chronic infections.
- Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \< 45%
- Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.
- History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs...
- Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
See the full eligibility criteria
- Patient is able to provide informed consent and sign approved consent forms to participate in the study.
- Patient age is at least 18 years old.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2.
- Histologically confirmed metastatic metastatic disease stage 4.
- Must have documented RAS (KRAS, HRAS, NRAS) mutation identified within the last 5 years by a local test on tumor tissue.
- More than 2 lines of standard drug antitumor therapy in the anamnesis.
- Must have disease progression as defined by RECIST version 1.1 criteria
- Appropriate hematologic and liver function:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/μL)
- Lymphocyte count ≥ 0.5 x 109/L (500/μL)
- Platelet count ≥ 100 x 109/L (100,000/μL) without transfusion
- Hemoglobin ≥ 90 g/L without transfusion.
- Creatinine clearance ≥ 40 mL/min
- Serum albumin ≥ 25 g/L (2.5 g/dL)
- Serum bilirubin ≤ 1.5 x HGH, with the following exception:
- Patients with known Gilbert's disease or liver metastases: serum bilirubin level ≤ 3 x IUH
- AST, ALT, and alkaline phosphate ≤ 2.5 x HGN; 10\. For women of childbearing potential: consent to abstinence (abstain from heterosexual intercourse) or use at least two forms of effective contraception with an...
- Age over 85 years.
- Рresence of acute or active chronic infections.
- Impaired renal and hepatic function; - left ventricular ejection fraction (LVEF) \< 45%
- Known history of acute or chronic hepatitis B or C due to known potential hepatotoxicity of leflunomide.
- History of allergic reactions associated with compounds similar in chemical or biological composition to leflunomide or teriflunomide or other drugs in the combination.
- Uncontrolled intercurrent disease, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or mental illness/social situations that limit...
- Patients should not be pregnant or breastfeeding due to the potential for teratogenic effects and side effects of planned chemotherapeutic regimens.
- History of retinal disease (retinal tear, exudate, hemorrhage) or retinal vein occlusion, central serous retinopathy or retinal pigment epithelium detachment, or current risk factors for ROS (e.g., uncontrolled glaucoma...
- Refusal to continue participation in the study.
- Intolerable toxicity.
- Progression according to RECIST 1.1 and IRECIST criteria or clinically significant (in the opinion of the physician) progression requiring a change in anticancer treatment.
- Non-compliance with IND procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.