Status:
UNKNOWN
Tolerance and Pharmacokinetics of TQ-B3233
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 toxic...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03453034
Start Date
November 22 2017
End Date
December 31 2018
Last Update
March 5 2018
Active Locations (1)
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1
Beijing cancer hospital
Beijing, China, 100142