Advanced Cancer
Conditions
Brief summary
The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.
Interventions
DRUGAnlotinib
in the fasting state
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma) * At least one measurable lesion (by RECIST1.1) * Lack of the standard treatment or treatment failure * 20≤BMI≤25 * 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months * 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
Exclusion criteria
* Clear allergies to the study drug or its ingredients * Had the disease to affect drug absorption and metabolism * Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.) * Brain metastases patients with symptoms or symptoms controlled \< 1 months * Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study * 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 * Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax) | up to 14 Days | Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour). |
| Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC) | up to 14 Days | Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax） | up to 14 Days | Peak time（Tmax）,Tmax in h.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour). |
Countries
China
Outcome results
None listed