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

NCT02825563 | Completed Phase 1

• 1 other identifier: ALTN-I-05
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

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

  up to 14 Days

Study Arms (2)

Anlotinib(In the fasting state)

EXPERIMENTAL

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

Anlotinib(In the high fat diet state)

EXPERIMENTAL

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

Interventions

Anlotinib DRUG

in the fasting state

Anlotinib(In the fasting state)

Eligibility Criteria

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

You may qualify if:

• 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
• ≤BMI≤25
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

anlotinib

Study Design

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

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 7, 2016
• Study Start: June 1, 2016
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: May 22, 2019

Record last verified: 2019-05

Locations

CN (1)