OncoMatch/Clinical Trials/NCT06540937
Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Is NCT06540937 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Leflunomide Pill for neuroendocrine tumors.
Treatment: Leflunomide Pill — This phase II trial studies aim to evaluate the initial efficacy of leflunomide tablets in second-line treatment of advanced MEN-1 neuroendocrine tumors, and to provide evidence for phase III clinical trials.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Neuroendocrine Tumor
Biomarker criteria
Required: MEN1 germ line mutation
MEN-1 germ line mutation (MEN-1 syndrome)
Required: MEN1 somatic mutation
tumor with somatic MEN-1 mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy — first-line
Unresectable neuroendocrine tumors that have failed standard first-line systemic therapy
Cannot have received: antitumor therapy
Received any antitumor therapy within 4 weeks
Lab requirements
Blood counts
leukocyte > 4.0×10^9/L, neutrophils ≥ 1.5×10^9/L, platelets ≥ 100×10^9/L, hemoglobin ≥ 10 g/dL
Kidney function
serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 ml/min
Liver function
total bilirubin < 1.5x ULN, AST/ALT ≤ 1.5x ULN, LDH ≤ 1.5x ULN, alkaline phosphatase ≤ 5x ULN
Bone marrow: leukocyte > 4.0×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥10g/dL; Liver: total bilirubin < 1.5 times the upper limit of normal, AST/ALT≤1.5 times the upper limit of normal value, Lactate dehydrogenase ≤1.5 times the upper limit of normal value, Alkaline phosphatase ≤5 times the upper limit of normal value; Kidney: serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance ≥60ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06540937 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antitumor therapy disqualifies patients from enrollment.
Does this trial require MEN1?
Yes, MEN1 germ line mutation is a required biomarker for enrollment.
Does this trial require MEN1?
Yes, MEN1 somatic mutation is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages