Clinical trial NCT02622932: Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
Official title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)
timeFrame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
measure: Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)
timeFrame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
measure: Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)
timeFrame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
measure: Excretion rate of 14C-labeled Anlotinib (radioactivity in feces)
timeFrame: up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)
measure: Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax)
timeFrame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax）
timeFrame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2）
timeFrame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
measure: Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL）
timeFrame: up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Secondary outcomes:
measure: Metabolite identification of Anlotinib in plasma, urine and feces
timeFrame: up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lihua Bao, Doctor
role: STUDY_DIRECTOR
References: