low-grade glioma
Conditions
Interventions
Experimental group:FCN-159, QD
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria for study entry: 1.Adult patients must be aged = 18 years old at the time of enrollment; pediatric patients must be aged from 2 to 15 1.5 Well coagulation function, international normalized ratio (INR) and activated partial thromboplastin time (APTT) = 1.5 × ULN; 10.For patients of childbearing potential: patients must agree to use highly effective contraceptive methods which is defined as combined hormonal contraceptives, ovulation-inhibiting progestin-only pills, intrauterine devices, intrauterine system, bilateral tubal occlusion, partner vasectomy or sexual abstinence during the treatment period and for at least 90 days after the last dose of study treatment. Male patients must agree to avoid sperm donation for at least 90 days after the last dose. (Note: If hormonal contraceptives are used, the particular contraceptives must have been taken for at least 3 months before the first administration of the study drug). 11.The patients or their legal guardians (if the patient is < 18 years old) are able to understand and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions shall not be included in this clinical study: 1.Patients who have previously received one of the following treatments: a. Have received chemotherapy or Traditional Chinese medicine or Chinese herbal medicines with explicit antitumor activity within 4 weeks before commencement of the study drug treatment; b. Received strong CYP3A4, CYP2C8 and CYP2C9 inhibitors or inducers within 14 days before administration of the study drug, except for topical use; c. Use of growth factors to increase the number or function of platelets or white blood cells within 7 days before administration of the study drug; d. Received radiotherapy, surgical intervention or immunotherapy within 4 weeks before administration of FCN-159; e. Participation in other interventional clinical trials within 4 weeks before administration of the study drug; f. Previous treatments with any MEK1/2 inhibitors such as selumetinib or treatments with BRAF inhibitors such as dabrafenib. 2.Patients with high-grade gliomas (grade 3 or 4). 3.Uncontrolled seizures. 4.Known to have an active autoimmune disorder or a history of autoimmune disease that requires systemic steroids and daily prednisone dose > 30 mg, dexamethasone > 5 mg, or equivalent dose of corticosteroids (the upper dose limit of steroids for pediatric patients is determined by the investigator based on the actual clinical situation) or immunosuppressive therapy (such as cyclophosphamide, azathioprine, methotrexate, thalidomide and TNF-a-pyrene antagonist, etc.) within 2 weeks of randomization; (Note: patients with topical inhaled bronchodilators or steroids, with stable hypothyroidism who require hormone replacement therapy and have stable disease should not be excluded). 5.Patients with a previous of other malignancy or with a concurrent other malignancy (other than almost cured basal cell carcinoma of non-melanoma skin, breast carcinoma in situ or in situ carcinoma of cervix. As well as other malignant tumors without any evidence of disease within 5 years). 6.Patients who are unable to undergo MRI examination and/or for whom MRI examination is contraindicated. 7.Uncontrolled stable hypertension (despite drug therapy): repeated examinations indicate systolic blood pressure or diastolic blood pressure > 150/100 mmHg with existing anti-hypertension therapy. 8.Patients with dysphagia, active digestive disorders, malabsorption syndrome, or other conditions that might affect the absorption of the study drug. 9.Patients with clinically significant active bacterial, fungal or viral infections, including hepatitis B virus surface antigen-positive and hepatitis B virus DNA over 1000 IU/mL, hepatitis B virus carriers are allowed to be enrolled. Those who are positive for hepatitis C virus (HCV) antibody test; confirmed human immunodeficiency virus (HIV) infection, and those who are unwilling to undergo HIV testing. 10.Previous or current retinal vein occlusion (RVO), retinal pigment epithelial detachments (RPED), central retinal vein occlusion (CRVO), glaucoma and other significant abnormality in ophthalmic examination. 11.Patients with cardiac dysfunction or concomitant diseases meeting any one of the following conditions will be excluded: a. Three 12-lead electrocardiogram (ECG) measurements were performed at the study site during the screening period for which the mean value of the three measurements was calculated according to the QTcF formula using the instru
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR:Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival,PFS;PK(pharmacokinetics) Parameters;Overall survival, OS;TEAE:Treatment-emergent adverse events;SAE:Serious Adverse Events;Adverse Events related to product; | — |
Countries
China
Contacts
Public ContactWenbin Li
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed