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

NCT ID: NCT02825563

Last Updated: 2019-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-08-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

in the fasting state

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

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

in the high fat diet

Interventions

Anlotinib

in the fasting state

Intervention Type: DRUG

Anlotinib

in the high fat diet

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

ALTN-I-05

Identifier Type: -

Identifier Source: org_study_id