Tolerance and Pharmacokinetics of TQ-B3233

Recruitment & Eligibility

Status: UNKNOWN

Sex: All

Target Recruitment: 50

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;

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQ-B3233 capsule	TQ-B3233	QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)	up to 28 Days
Peak time(Tmax)	up to 28 Days
Half life(t1/2)	up to 28 Days
maximum tolerated dose(MTD)	28 Days
dose-limiting toxicity(DLT)	28 Days
Peak Plasma Concentration(Cmax)	up to 28 Days

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	up to 24 months

Tolerance and Pharmacokinetics of TQ-B3233

Recruitment & Eligibility

Study & Design

Trial Locations

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