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A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics.To further study the pharmacokinetic characteristics of Anlotinib in the human body, recommend a reasonable regimen for subsequent research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib QD po. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax) | Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day). | up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of Anlotinib (in whole blood):Peak time(Tmax) | Peak time(Tmax),Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day). | up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of Anlotinib (in whole blood):Half life(t1/2) | Half life(t1/2),t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H mans Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day). | up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC) | Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day). | up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD(Disease progression) (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are used by anlotinib
Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.)
Brain metastases patients with symptoms or symptoms controlled < 3 months
Patients with any severe and/or unable to control diseases,including:
Patients with non-healing wounds or fractures
Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
Patients with drug abuse history and unable to get rid of or Patients with mental disorders
Patients participated in other anticancer drug clinical trials within 4 weeks
History of immunodeficiency
Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
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| 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 |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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| Pharmacokinetics of Anlotinib (in whole blood):Clearance(CL) | Clearance(CL),CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H72/H120/H168/H240(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D7/D10/D14/D18/Before the next cycle(D means Day). | up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Cumulative excretion of Anlotinib (in urine) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) |