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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825563
• Other study ID #: ALTN-I-05
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: August 15, 2018

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 15, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• Anlotinib
in the fasting state
• Anlotinib
in the high fat diet

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of Anlotinib (in whole blood):Peak Plasma Concentration(Cmax)	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
Primary	Pharmacokinetics of Anlotinib (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.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	Pharmacokinetics of Anlotinib (in whole blood):Peak time(Tmax)	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