Status:
UNKNOWN
A New Drug Used for Advanced Cancer
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
To identify the safety and tolerance of TQ-B3203.
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
December 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03447145
Start Date
December 26 2017
End Date
December 26 2018
Last Update
February 27 2018
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100021