MedTrace Logo

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

NCT06229340 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-29

No results posted yet for this study

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.

Conditions

  • RAS Mutation
  • Ras (Kras or Nras) Gene Mutation
  • Colorectal Cancer Recurrent
  • Pancreas Cancer
  • Lung Cancer
  • Melanoma
  • Refractory Cancer

Interventions

DRUG

Leflunomide

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

DRUG

The 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.

Sponsors & Collaborators

  • N.N. Petrov National Medical Research Center of Oncology

    lead OTHER

Principal Investigators

  • Evgeny Imyanitov · N.N. Petrov NMRC of Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-03
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06229340 on ClinicalTrials.gov