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

May 20, 2019 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Phase I Additional 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anlotinib(In the fasting state)
In the fasting state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
in the fasting state
Drug: Anlotinib
in the high fat diet
Experimental: Anlotinib(In the high fat diet state)
In the high fat diet state, Anlotinib po only once and after 14 days it could be continued by Qd po.until disease progression or intolerable toxicity or patients withdrawal of consent
Drug: Anlotinib
in the fasting state
Drug: Anlotinib
in the high fat diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 14 Days
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).
up to 14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 14 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

August 15, 2018

Study Completion (Actual)

August 15, 2018

Study Registration Dates

First Submitted

June 29, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTN-I-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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