A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2）
Study Overview
Brief Summary
The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer patients.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Anlotinib and 14C-labeled Anlotinib
each participant will be given a single dose of 14C-labeled gilteritinib.
Intervention: Anlotinib and 14C-labeled Anlotinib (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2）
Time Frame: 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)
Time Frame: 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）
Time Frame: 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)
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): Area under the plasma concentration versus time curve (AUC)
Time Frame: 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)
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): Clearance（CL）
Time Frame: 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 Outcomes
- Metabolite identification of Anlotinib in plasma, urine and feces(up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%))