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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

Anlotinib and 14C-labeled AnlotinibDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)

Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)

Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)

Time frame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Excretion rate of 14C-labeled Anlotinib (radioactivity in feces)

Time frame: 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,

Time frame: 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.

Time frame: 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.

Time frame: 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)

Data from ClinicalTrials.gov

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes