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

• Status: Completed
• Trial end date: 2018-08-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

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