RecruitingPhase 2NCT06229340

Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations

New Therapeutic Approaches for Tumors With RAS Gene Mutations


Sponsor

N.N. Petrov National Medical Research Center of Oncology

Enrollment

20 participants

Start Date

Oct 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing two treatment options — leflunomide alone, or a combination of a MEK inhibitor and hydroxychloroquine — for patients with advanced metastatic cancers that have a RAS gene mutation (such as KRAS, HRAS, or NRAS) and have stopped responding to standard treatments. **You may be eligible if...** - You are 18 or older with confirmed stage 4 metastatic cancer - Your tumor has a documented RAS mutation (KRAS, HRAS, or NRAS) identified within the last 5 years - You have already received more than 2 prior lines of standard treatment - Your cancer is progressing on current therapy - Your blood counts and organ function meet required minimums **You may NOT be eligible if...** - You have not yet tried standard therapies - Your organ function is inadequate - You are pregnant or breastfeeding - You have serious uncontrolled medical conditions or active infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLeflunomide

100 mg daily for 3 days at the loading dose, then 20 mg daily at the standard dose.

DRUGThe combination of MEK inhibitor + hydroxychloroquine( plaquenil) ± bevacizumab

Use of one of the possible MEK-inhibitor options: Trametinib 2 mg once daily orally; Cobimetinib 60 mg on days 1-21, break 7 days, cycle 28 days orally; Binimetinib 45 mg 2 times a day daily orally. + Hydroxychloroquine 600 mg 2 times a day daily orally. ± Bevacizumab 7.5 mg/m² every 3 weeks intravenously.


Locations(1)

Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology, Saint Petersburg, Russian Federation

Saint Petersburg, Russia

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NCT06229340


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