malignant melanoma of head and neck mucosa
Conditions
Interventions
SHR6390 group:SHR6390 group was given orally
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 to 75 years); 2. Patients with recurrent or metastatic mucosal malignant melanoma located in the oral cavity, oropharynx, nasopharynx and other head and neck mucosa, diagnosed as melanoma according to the pathological diagnostic criteria according to the WHO pathology and genetics of head and neck tumors, and stage III or IV according to AJCC eighth edition, who are unable to receive surgical treatment or refuse to receive surgical treatment; 3. CDK4 amplification (fish +) was confirmed in tumor tissue by gene detection; 4. Complete the imaging examination of head and neck lesions before enrollment, and at least one measurable lesion without local treatment (must have at least one evaluable lesion judged according to RECIST version 1.1 standard, i.e., the longest diameter should be at least 10 mm; if the CT scan slice thickness is more than 5 mm, the minimum diameter of the lesion should be 2 times of the slice thickness; if the lesion is a lymph node, the short diameter should be at least 15 mm); 5. Be able to swallow the tablets normally; 6. ECoG score 0 ~ 1; 7. Expected survival time >=12 weeks; 8. The function of important organs and bone marrow meets the following requirements (no blood transfusion or blood products within 14 days before screening) (1) Blood routine examination: absolute count of neutrophil (ANC) >=1.5x10^9/L, lymphocyte (LC) >=2x10^9/L, platelet (PLT) >=100x10^9/L, hemoglobin (Hgb) >=9g/dl; (2) Liver function: serum total bilirubin (TBIL) =2.8 g/dl; (3) Renal function: serum creatinine (CR) =40 ml / min (using standard Cockcroft Gault formula); (4) Thyroid function: thyroid stimulating hormone (TSH) <=1 ULN (if abnormal, FT3 and FT4 levels should be examined at the same time; if FT3 and FT4 levels are normal, they can be included in the group); Nine Female patients of non-surgical sterilization or childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 3 months after the end of the study treatment period; the serum or urine HCG test of non-surgical sterilization women of childbearing age must be negative within 72 hours before study enrollment; and they must be non lactating; for partners, they should be in non lactation period Male patients of childbearing age women should use effective contraceptive methods during the trial and within 3 months after the last shr6390 administration. 10. The subjects volunteered to join the study, signed the informed consent, and could cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received any kind of CDK4 / 6 inhibitors; 2. Patients who had previously received radiotherapy, chemotherapy, hormone therapy, surgery, and less than 4 weeks before the study medication after the completion of treatment (the last medication); patients whose half-life of molecular targeted therapy (including oral targeted drugs for other clinical trials) less than 5 drugs from the first study medication, or patients whose adverse events (except hair loss) caused by previous treatment did not recover to =10^4 copies/ml, HCV >=10^3 copies/ml); 10. NCI CTCAE grade 2 toxicity before inclusion; 11. Any second primary malignant tumor was diagnosed within 5 years; 12. The following conditions occurred 6 months before administration: severe / unstable angina pectoris, myocardial infarction, congestive heart failure with symptoms, cerebrovascular accident, including transient ischemic attack, pulmonary embolism, renal insufficiency >=grade 2, and other severe diseases judged by investigators; 13. Take strong CYP3A4 inhibitor within 7 days before enrollment; 14. Active arrhythmia with NCI CTCAE grade >=2; 15. Suffering from hypertension and can not be well controlled by antihypertensive drugs (SBP >=150 mmHg or DBP >= 100 mmHg); 16. Patients were treated with warfarin > 2 mg within 2 weeks before enrollment. Low dose warfarin (< 2 mg / 3day) is permitted to prevent DVT. Low molecular weight heparin (fractionation) or aspirin is also allowed; 17. The presence of any disease that affects drug absorption, including but not limited to: inability to swallow oral medication, active inflammatory bowel disease, partial or complete obstruction, partial or total gastrectomy, extensive enterotomy or chronic diarrhea; 18. Human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, or congenital immunodeficiency diseases, organ transplantation history; 19. Pregnant and lactating women, or fertile women without contraceptive measures. Negative pregnancy tests (serum or urine) were required for all female patients with reproductive potential within 7 days before enrollment and on the first day of each visit cycle; 20. Other severe, acute or chronic medical or mental illness or laboratory abnormalities that, in the opinion of the investigator, may increase the risk associated with participating in the study, or may interfere with the interpretation of the results of the study; 21. Patients who participated in other clinical trials at the same time, except for non therapeutic clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactGuoxin Ren
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed