Mucosal Melanoma of Head and Neck
Conditions
Interventions
Experimental group:SHR6390
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged 18-75 (including those aged 18 and 75); 2. Histologically diagnosed with recurrent and/or metastatic mucosal melanoma of head and neck (oral cavity, oropharynx, hypopharynx, or larynx) according to the WHO Pathology and Genetics of Head and Neck Tumors. Unresectable patients were assessed by principle investigator including having received surgery and adjuvant treatment with curative intent, failure of adjuvant therapy or stopping taking chemotherapy drugs for more than 3 months; 3. Tumor tissue confirmed as CDK4 amplification by FISH; 4. At least one measurable lesion that has not been treated locally. According to the RECIST version 1.1 standard, the longest diameter of evaluable lesion is at least 10 mm; if the CT scan layer thickness is > 5 mm, the minimum diameter of lesion should be 2 times of CT scan layer thickness; if the lesion is a lymph node, the short diameter should be at least 15 mm); 5. Can swallow pills normally. 6. ECOG performance status 0 or 1 before treatment; 7. Expected survival >= 12 weeks; 8. The function of vital organs meets the following requirements (no blood components, cell growth factors and other corrective medications are allowed within 14 days prior to screening: a) the absolute count of neutrophils is >= 1.5 x 10^9/L; lymphocyte >= 2 x 10^9 / L; platelets >= 100 x 10^9 / L; hemoglobin >= 90 g / L; b) Liver function: serum TBIL = 28g / L; c) Renal function: Cr = 40 mL/min (using the standard Cockcroft-Gault formula); d) Thyroid function: thyroid stimulating hormone (TSH) <= 1 x ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time; if the FT3 and FT4 levels are normal, can be included); 9. Women with non-surgical sterilization or women of childbearing age need to use a medically approved contraceptive (such as an intrauterine device, contraceptive or condom) during the study period and within 3 months after the end of the study treatment period; Female patients of childbearing age who havent undergone surgical sterilization must have a negative serum or urine HCG test within 72 hours prior to study enrollment, and must be non-lactating; for male patients with a partner of childbearing age, effective method of contraception should be given during the trial and within the next 3 months at the end of the trial. 10. Patients voluntarily participate in and sign informed consent, and can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or current administration of any kind of CDK4/6 inhibitors; 2. Has allergic diseases, history of severe drug allergies, hypersensitivity to SHR6390 or any excipients of SHR6390; 3. Administration of any other anti-tumor therapy (including but not limited to radiotherapy, chemotherapy, endocrinal therapy, surgery, molecular targeted therapy, immunotherapy or biological therapy) within 4 weeks before inclusion; molecular targeted therapy (including other oral targeted drugs for clinical trials) within 5 drug half-life before first dose, or patients who did not recover from adverse events caused by previous treatment to = 104 copies/mL, HCV >= 103 copies/mL); 10. NCICTCAE Grade 2 toxicity before enrollment; 11. Diagnosed as any second primary malignant tumor in 5 years before enrollment; 12. Following conditions occur in the 6 months before drug administration: severe/ unstable angina pectoris, myocardial infarction, congestive heart failure with symptoms, cerebrovascular accident, including transient ischemic attack, pulmonary embolism, >= grade II renal dysfunction, and other severe diseases that investigators judged to be unsuitable for this trial; 13. Administration of potent CYP3A4 inhibitors in 7 days before enrollment; 14. NCICTCAE Grade >= 2 Active arrhythmias; 15. Hypertension, defined as systolic blood pressure > 150mmHg and/or diastolic blood pressure > 100mmHgand cannot be controlled by medication; 16. No recommendation to receive > 2 mg Warfarin treatment in 2 weeks before study beginning. It is permitted to use low dose Warfarin(<2 mg / 3day) to prevent deep venous thrombosis. Low molecular weight heparin (fractionated) or aspirin are also allowed; 17. Existence of any disease affecting drug absorption, including but not limited to: no ability to swallow oral medications, active inflammatory bowel disease, and partial or complete obstruction, partial or total gastrectomy, extensive bowel resection or chronic diarrhea; 18. Known infection of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or congenital immune deficiency diseases, organ transplantation history; 19. Pregnancy, breastfeeding, childbearing age female who is reluctant to take effective contraceptive measures throughout trial period. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within 7 days before randomization and at first day of every cycle on visit; 20. Other severe acute or chronic physiological or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study; 22. Current treatment on another clinical trial. Non-therapeutic clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events;Objective Response Rate, ORR;Progression Free Survival, PFS;Overall Survival, OS; | — |
Countries
China
Contacts
Public ContactZhiyuan Zhang
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed