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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622932
• Other study ID #: ALTN-I-R
• Status: Completed
• Phase: Phase 1
• Start date: December 2, 2015
• Est. completion date: August 2017

Study information

• Verified date: April 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2017
• Est. primary completion date: December 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• Anlotinib and 14C-labeled Anlotinib
oral

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)		up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Primary	Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)		up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Primary	Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)		up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Primary	Excretion rate of 14C-labeled Anlotinib (radioactivity in feces)		up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Metabolite identification of Anlotinib in plasma, urine and feces		up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)