Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor
Recruiting now · Phase 2
Conditions studied: Neuroendocrine Tumors
In brief
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.
Key facts
- Study ID
- NCT06540937
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 50
- Starts
- 2020-07-01
- Expected to finish
- 2024-12-30
- Last updated by the study team
- 2024-08-07
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years, gender unlimited
- Pathological diagnosis of neuroendocrine tumor
- MEN-1 germ line mutation (MEN-1 syndrome), or tumor with somatic MEN-1 mutation
- Unresectable neuroendocrine tumors that have failed standard first-line systemic therapy
- At least one evaluable lesion according to the RECIST criteria
- ECOG physical condition score: 0-1
- Voluntarily joined the study, signed the informed consent, complied well, and cooperated with the follow-up.
- Must meet the following requirements: 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
You may not qualify if…
- Received any antitumor therapy within 4 weeks
- Participated in or are participating in clinical trials of other drugs/therapies within 4 weeks prior to the initial use of the study drug
- Underwent/received major surgery or has not recovered from the side effects of the surgery within 4 weeks prior to the initial use of the study drug
- Subjects of other malignant tumors unless complete remission was achieved at least 2 years prior to study inclusion and not required other treatment during the study period
- Persistent or active (serious) infection
- Hypertension that is difficult to control with medication (continuous blood pressure is greater than 150/90 MMHG
- Poorly controlled diabetes
- Grade II/IV congestive heart failure or heart block
- Within 6 months prior to use for the first time seen in the following situations:
- Deep vein thrombosis; Pulmonary embolism; Myocardial infarction; Serious arrhythmia; Instability or angina pectoris; Percutaneous coronary intervention; Acute coronary syndrome; Coronary artery bypass grafting
- Be allergic to leflunomide tablets and their metabolites
- Severe liver damage
- Other severe acute or chronic medical conditions or abnormalities in laboratory tests that may increase the risks associated with study participation or may interfere with the interpretation of study results
- Poor compliance, or other conditions unsuitable for participation in this trial
Where it is running
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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