Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
Phase 1
Completed
- Conditions
- Advanced Solid Tumors
- Interventions
- Registration Number
- NCT02622932
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of \[14C\] Anlotinib in Patients With Advanced Cancer patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anlotinib and 14C-labeled Anlotinib Anlotinib and 14C-labeled Anlotinib each participant will be given a single dose of 14C-labeled gilteritinib.
- Primary Outcome Measures
Name Time Method 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):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.
Cumulative excretion 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 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): 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.
Cumulative excretion 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): 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.
- Secondary Outcome Measures
Name Time Method Metabolite identification of Anlotinib in plasma, urine and feces up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Trial Locations
- Locations (1)
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China