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Completed

NCT Number: NCT02825563

A Phase I Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients

The purpose of this study is to further study the pharmacokinetic characteristics of Anlotinib in Advanced Cancer Patients with High Fat Diet.

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Key information

Conditions

Advanced Cancer

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histological documentation of Advanced solid tumors( Non-small Cell Lung Cancer.Soft Tissue SarcomaMedullary. Thyroid Carcinoma)
  • At least one measurable lesion (by RECIST1.1)
  • Lack of the standard treatment or treatment failure
  • 20≤BMI≤25
  • 18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
  • Main organs function is normal
  • Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
  • Patients should participate in the study voluntarily and sign informed consent

Exclusion criteria

  • Clear allergies to the study drug or its ingredients
  • Had the disease to affect drug absorption and metabolism
  • Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)
  • Brain metastases patients with symptoms or symptoms controlled < 1 months
  • Used any drugs inhibit or induce hepatic drug metabolic enzymes in 30 days before the study
  • Patients with drug abuse history and unable to get rid of or Patients with mental disorders
  • Patients participated in other anticancer drug clinical trials within 4 weeks
  • Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Treatment and study plan

Anlotinib

Drug

in the fasting state

Primary outcomes

  1. Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)

    Time frame: up to 14 Days

    Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).

  2. Pharmacokinetics of Anlotinib (in whole blood):Area under the plasma concentration versus time curve (AUC)

    Time frame: up to 14 Days

    Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).

Secondary outcomes

  1. Pharmacokinetics of Anlotinib (in whole blood):Peak time（Tmax）

    Time frame: up to 14 Days

    Peak time（Tmax）,Tmax in h.In the study , full PK profiles will be obtained at H0/H1/H2/H4/H8/H11/H24/H48/H96/H144/H192/H240/H336(H mans Hour).

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

Phase I Additional Study of Anlotinib on Pharmacokinetics to Assess the Effect of High Fat Diet in Advanced Cancer Patients

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
May 22, 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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