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| Name | Class |
|---|---|
| Nanjing Medical University | OTHER |
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Anlotibib (ALTN) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.
ALTN is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2 and VEGFR3. It has the obvious resistance to new angiogenesis.
The primary objective of this trial is to explore the maximum tolerated dose(MTD), dose-limiting toxicity(DLT) of ALTN and rational dosage regimen for phase II study, to investigate the pharmacokinetics with single and multiple doses of ALTN from 5mg/d,10mg/d,16mg/d,12mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anlotinib | Experimental | dosage form:capsule dosage:5mg,10mg,16mg,12mg frequency:once one day duration:Continuous two weeks then stop a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anlotinib | Drug | oral medicine. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tmax Cmax t1/2 AUC | To collect point with single drug:H0/H0.5/H1/H2/H4/H8/H12/H24/H48/H72/H96/H120/H144/H/H168/H192/H216/H240 To collect point with multiple drug:d1/d2/d4/d7/d10/d14/d15/d21/d22/d28/d35/d42 | Up to 52 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | blood examination, urine examination, stool examination, blood biochemical (ALT, AST, TB(total bilirubin), DB, BUN, Cr, blood electrolyte), electrocardiogram (ecg), thyroid function, the function of blood coagulation, etc | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| tumor size | To evaluate the effectiveness of ALTN by enhanced CT scan every two cycles. Refer to recist 1.1. | Up to 42 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yihebali Chi, doctor | Cancer Institude and hospital,CAMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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