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

NCT02622932 | Completed Phase 1

• 1 other identifier: ALTN-I-R
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Metabolite identification of Anlotinib in plasma, urine and feces

  up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)

Study Arms (1)

Anlotinib and 14C-labeled Anlotinib

EXPERIMENTAL

each participant will be given a single dose of 14C-labeled gilteritinib.

Drug: Anlotinib and 14C-labeled Anlotinib

Interventions

Anlotinib and 14C-labeled Anlotinib DRUG

oral

Anlotinib and 14C-labeled Anlotinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

MeSH Terms

Interventions

anlotinib

Study Officials

• Lihua Bao, Doctor

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 7, 2015
• Study Start: December 2, 2015
• Primary Completion: December 30, 2016
• Study Completion: August 1, 2017
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

CN (1)