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NCT Number: NCT02622932

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anlotinib and 14C-labeled Anlotinib

Drug

oral

Primary outcomes

  1. 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%)

  2. 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%)

  3. 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%)

  4. 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%)

  5. 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,

  6. 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.

  7. 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.

  8. 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.

  9. 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

  1. Metabolite identification of Anlotinib in plasma, urine and feces

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

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 7, 2015
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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