Cancer Clinical Trial
Official title:
Phase I Study of Tolerance and Pharmacokinetics of TQ-B3203
To identify the safety and tolerance of TQ-B3203.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 26, 2018 |
Est. primary completion date | December 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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); |
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The maximum tolerated dose(MTD) | 21 days | ||
Primary | dose-limiting toxicity(DLT) | 21 days | ||
Primary | Peak Plasma Concentration(Cmax) | 21 days | ||
Primary | Peak time(Tmax) | 21 days | ||
Primary | Half life(t1/2) | 21 days | ||
Primary | Area under the plasma concentration versus time curve (AUC) | 21 days | ||
Primary | Clearance(CL) | 21 days | ||
Secondary | Objective Response Rate(ORR) | each 42 days up to intolerance the toxicity or progression disease (up to 24 months) |
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