Tolerance and Pharmacokinetics of TQ-B3233
- Registration Number
- NCT03453034
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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）.
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 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 Area under the plasma concentration versus time curve (AUC) up to 28 Days Peak Plasma Concentration(Cmax) up to 28 Days
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 24 months
Trial Locations
- Locations (1)
Beijing cancer hospital
🇨🇳Beijing, China
Beijing cancer hospital🇨🇳Beijing, ChinaJun Guo, doctorContact010-88196317guoj307@126.com