Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients.

Official Title
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A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: Anlotinib and 14C-labeled Anlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib and 14C-labeled Anlotinib<br>each participant will be given a single dose of 14C-labeled gilteritinib. | Drug: Anlotinib and 14C-labeled Anlotinib<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Peak Plasma Concentration(Cmax),Cmax in ng/mL, | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax） | Peak time（Tmax）,Tmax in h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2） | Half life（t1/2）,t1/2 in h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity 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. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 
| Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL） | Clearance（CL）,CL in L/h. | up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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%) |