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

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: Anlotinib and 14C-labeled Anlotinib

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib and 14C-labeled Anlotinib; each participant will be given a single dose of 14C-labeled gilteritinib.	Drug: Anlotinib and 14C-labeled Anlotinib; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)		up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)		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):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)
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)
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)
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)
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 Outcome Measures

Outcome Measure	Time Frame
Metabolite identification of Anlotinib in plasma, urine and feces	up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Investigators: Study Director: Lihua Bao, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2015
• Primary Completion (Actual): December 30, 2016
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: December 4, 2015
• First Posted (Estimate): December 7, 2015

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 27, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: ALTN-I-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED