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

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

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: Anlotinib
* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib(In the fasting state)<br>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<br>* in the fasting state<br>|
| Experimental: Anlotinib(In the high fat diet state)<br>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<br>* in the high fat diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |