A Phase I Additional Study of Anlotinib on Tolerance and Pharmacokinetics
- Registration Number
- NCT02752516
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- Histological documentation of Advanced solid tumors except the digestive tract tumors,at least one measurable lesion (by RECIST1.1)
- Lack of the standard treatment or treatment failure
- 18-65 years,ECOG PS:0-1,Life expectancy of more than 3 months
- 30 Days or more from the last cytotoxic therapy
- 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 participate in the study voluntarily and sign informed consent
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Patients who are used by anlotinib
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Patients with factors that could affect oral medication (such as dysphagia,chronic diarrhea, intestinal obstruction etc.)
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Brain metastases patients with symptoms or symptoms controlled < 3 months
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Patients with any severe and/or unable to control diseases,including:
- Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg,diastolic pressure≥100 mmHg);
- Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);
- Patients with active or unable to control serious infections;
- Patients with cirrhosis, decompensated liver disease, or active hepatitis;
- Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)
- Urine protein ≥ ++,and 24-hour urinary protein excretion>1.0 g confirmed
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Patients with non-healing wounds or fractures
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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
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Patients with drug abuse history and unable to get rid of or Patients with mental disorders
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Patients participated in other anticancer drug clinical trials within 4 weeks
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History of immunodeficiency
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Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anlotinib Anlotinib -
- Primary Outcome Measures
Name Time Method Pharmacokinetics of Anlotinib (in whole blood):Half life(t1/2) up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) 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).
Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax) up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) 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).
Pharmacokinetics of Anlotinib (in whole blood):Peak time(Tmax) up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) 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).
Pharmacokinetics of Anlotinib (in whole blood):Clearance(CL) up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) 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).
Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC) up to 18 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) 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).
Cumulative excretion of Anlotinib (in urine) up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) each 42 days up to intolerance the toxicity or PD(Disease progression) (up to 24 months)
Trial Locations
- Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences🇨🇳Beijing, Beijing, China