A New Drug Used for Advanced Cancer

Study Overview
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Brief Summary
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To identify the safety and tolerance of TQ-B3203.

Official Title
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Phase I Study of Tolerance and Pharmacokinetics of TQ-B3203

Conditions
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Cancer

Intervention / Treatment
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* Drug: TQ-B3203


Participation Criteria
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Eligibility Criteria
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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);

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3203<br> | Drug: TQ-B3203<br>* dose escalation, 2/4/6/10/14/18mg/m2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Clearance（CL） |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate(ORR) |  | each 42 days up to intolerance the toxicity or progression disease (up to 24 months) |