Advanced Solid Tumors
Conditions
Brief summary
The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of \[14C\] Anlotinib in Patients With Advanced Cancer patients.
Interventions
DRUGAnlotinib and 14C-labeled Anlotinib
oral
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* signed and dated informed consent * histologically or cytologically confirmed diagnosis of advanced solid tumor (including RCC、NSCLC、STS and CRC) * failed to the treatment of line 1 or 2 * ECOG PS:0-1,Life expectancy of more than 3 months * main organs function is normal
Exclusion criteria
* prior treatment with Anlotinib or Allergic to drug or its formulation ingredients * subjects with the gastrointestinal tract, liver and kidney disease of affect drug absorption and metabolism * CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments * patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea \[Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life\]) * patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL） | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | Clearance（CL）,CL in L/h. |
| Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | — |
| Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | — |
| Excretion rate of 14C-labeled Anlotinib (radioactivity in urine) | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) | — |
| Excretion rate of 14C-labeled Anlotinib (radioactivity in feces) | up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%) | — |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax) | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | Peak Plasma Concentration(Cmax),Cmax in ng/mL, |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax） | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | Peak time（Tmax）,Tmax in h. |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2） | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | Half life（t1/2）,t1/2 in h. |
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC) | up to 10 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. |
Secondary
| Measure | Time frame |
|---|---|
| Metabolite identification of Anlotinib in plasma, urine and feces | up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%) |
Countries
China
Outcome results
None listed