Tolerance and Pharmacokinetics of TQ-B3233

• Status: Unknown status
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Criteria

Inclusion Criteria:

• Patients definitely diagnosed by pathology and/or cytology as BRAF mutation advanced malignant melanoma.

• 18-70 years old, ECOG PS:0-1,Life expectancy of more than 3 months;

• Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 4 weeks, 6 weeks will be needed if agents were nitrocarbamide and mitomycin C;

• Main organs function is normal;

• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped;

• Patients should be voluntary and sign the informed consent before taking part in the study;

Exclusion Criteria:

• Patients with Malignant tumors within 5 years, except for non-melanoma skin cancer and in situ cancer;

• Patients who had previously received specific BRAF inhibitors;

• A variety of factors that affect oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.)

• Patients who participated in other anticancer drug clinical trials within 4 weeks ;

• Blood pressure unable to be controlled ideally by one drug(systolic pressure≥150 mmHg，diastolic pressure≥90 mmHg);

• Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias or cardiac insufficiency (including QTc≥480ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification);

• Patients with non-healing wounds or fractures;

• Patients with brain metastasis, spinal cord compression, cancerous meningitis, CT or MRI examination reminds patients with cerebral or soft meningeal diseases in the screening phase;

• Patients with drug abuse history or unable to get rid of drugs or Patients with mental disorders;

• Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy;

• Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;

• Patients with thyroid dysfunction;

• Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;

• Parents with hepatitis b surface antigen positive or HCV;