Cancer
Conditions
Brief summary
To identify the safety and tolerance of TQ-B3203.
Interventions
DRUGTQ-B3203
dose escalation, 2/4/6/10/14/18mg/m2
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance（CL） | 21 days |
| The maximum tolerated dose(MTD) | 21 days |
| dose-limiting toxicity(DLT) | 21 days |
| Peak Plasma Concentration(Cmax) | 21 days |
| Peak time（Tmax） | 21 days |
| Half life（t1/2） | 21 days |
| Area under the plasma concentration versus time curve (AUC) | 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR) | each 42 days up to intolerance the toxicity or progression disease (up to 24 months) |
Countries
China
Contacts
Primary Contactwang zi ping, doctor
Outcome results
None listed