Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2017-11-22
2018-12-31
Brief Summary
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Detailed Description
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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）.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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TQ-B3233 capsule
QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.
TQ-B3233
QD or BID in different stage of this research
Interventions
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TQ-B3233
QD or BID in different stage of this research
Eligibility Criteria
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Inclusion Criteria
* 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 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;
18 Years
70 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing cancer hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TQ-B3233-I-01
Identifier Type: -
Identifier Source: org_study_id
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