Tumor
Conditions
Keywords
TQ-B3233, tumor, toleration, pharmacokinetics
Brief summary
Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
Detailed description
The maximum tolerated dose (MTD) of TQ-B3233 \[ Time Frame: 48 weeks \] \[ Designated as safety issue: Yes \]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment. Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28（D means Day）.
Interventions
DRUGTQ-B3233
QD or BID in different stage of this research
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration(Cmax) | up to 28 Days |
| maximum tolerated dose(MTD) | 28 Days |
| dose-limiting toxicity(DLT) | 28 Days |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | up to 24 months |
Countries
China
Contacts
Primary ContactGuo Jun, doctor
Outcome results
None listed