A New Drug Used for Advanced Cancer
- Registration Number
- NCT03447145
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
To identify the safety and tolerance of TQ-B3203.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Patients definitedly diagnosed by pathology and/or cytology as advanced solid tumor,those who lack of standard treatments or treatment failure;
- Patients treated with chemotherapy agents or surgery before being enrolled into the study need waiting for 30 days, 6 weeks will be needed if agents were Nitrocarbamide and Mitomycin C
- 18-70 years old,Eastern Cooperative Oncology Group(ECOG):0-1,Life expectancy of more than 3 months,BMI:18.5-26;
- 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 consents 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 participated in other anticancer drug clinical trials within 4 weeks;
- Patients treated with Irinotecan,Topotecan and any other topoisomerase I inhibitors or related clinical trials;
- Patients of double locus mutation of UGT1A1*6、UGT1A1*28;
- Patients who cannot stop using inhibitors of CYP3A4 and UGT1A1 7 days before enrolled in the study,inducers of CYP3A4 need 2 weeks.
- Patients who can not be injected and patients with interstitial pneumonia or radiation pneumonia;
- Patients with pericardial effusion,pleural effusion or ascitic fluid, patients with 2nd respiratory syndrome or above are refused according to National Cancer Institute Common Terminology Criteria for Adverse Events(CTC AE);
- 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;
- Patients with non-healing wounds or fractures;
- Patients got radiotherapy for bone metastases 2 weeks before being enrolled in the study;
- Patients with urine pro 2+ and the quantitative result>1.0g
- Patients got Arteriovenous thrombosis 6 months before being the study "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 immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history;
- Patients with thyroid dysfunction;
- Patients diagnosed with glaucoma,or prostatomegaly need to be treated;
- Coagulation function abnormality: haemorrhagic tendencies (e.g. active digestive tract ulcer), or are receiving thrombolytic or anticoagulant therapy
- Patients with concomitant diseases which could seriously endanger themselves or those who won't complete the study according to investigators;
- Patient with hepatitis b surface antigen positive(HBV DNA>1000) or hepatitis C virus(HCV);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ-B3203 TQ-B3203 -
- Primary Outcome Measures
Name Time Method Half life（t1/2） 21 days Clearance（CL） 21 days The maximum tolerated dose(MTD) 21 days Peak Plasma Concentration(Cmax) 21 days Peak time（Tmax） 21 days dose-limiting toxicity(DLT) 21 days Area under the plasma concentration versus time curve (AUC) 21 days
- Secondary Outcome Measures
Name Time Method Objective Response Rate(ORR) each 42 days up to intolerance the toxicity or progression disease (up to 24 months)
Trial Locations
- Locations (1)
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China