Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-24 @ 5:42 PM
NCT ID:
NCT03639168
Eligibility Criteria:
Inclusion Criteria:
1. Age range 18-75 years old
2. Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
3. Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
4. Eastern Cooperative Oncology Group performance status 0 to 2;
5. Patients have written informed consent to participate in the study;
6. anticipated to live ≧3 months;
7. Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
8. total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 3× ULN
9. serum creatine \<1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
10. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
11. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
Exclusion Criteria:
1. Previously treated with HDACi;
2. Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
4. HIV, HCV, or syphilis infection；
5. Pregnant or lactating women;
6. Serious uncontrolled infection;
7. Severe neurol of mental illness, including dementia and epilepsy;
8. Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
9. Participated in other clinical trials in 4 weeks;
10. Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
11. History of QTc interval prolongation (Male \>450ms，Female \>470ms), ventricular tachycardia, auricular fibrillation, heart block of more than II degrees, myocardial infarction in 1 year, congenital heart disease, with symptomatic coronary heart disease requiring medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03639168
Study Brief:
Protocol Section:
NCT03639168