Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients

NSCLC Clinical Trial

Official title:

A Multi-center, Open-label, Fixed-sequence Study of Effect of Gefitinib on the Pharmacokinetics of Apatinib Mesylate in Non-squamous, Non-small-cell Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390984
• Other study ID #: HR-APTN-DDI-004
• Status: Recruiting
• Phase: Phase 1
• Start date: May 26, 2020
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yuya Wang, Ph.D
• Phone: 13918749176
• Email: wangyuya[@]hrglobe.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients. The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: March 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years of age.

2. ECOG performance status: level 0~1;

3. Anticipated life expectancy = 12 weeks;

4. Lung cancer patients;

5. Major organs in good function;

6. Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;

7. Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion Criteria:

1. History of drug allergy, or allergic to apatinib or gefitinib or ingredients;

2. Squamous cancer, small-cell lung cancer;

3. Symptomatic central nervous system (CNS) metastases

4. Hypertension and couldn't be controlled with medicine;

5. Coagulation disorders;

6. Clinical significant bleeding in 3 months prior dosing;

7. Had surgery in four weeks prior dosing;

8. Disease that affect drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;

9. Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess in 6 months prior dosing;

10. Urine protein =++, and urine protein =1.0g in 24 hours;

11. Active infection and need antimicrobial treatments;

12. History of psychiatric substance abuse;

13. Take any clinical trial drugs within four weeks prior dosing;

14. Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A and CYP2D6;

15. Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;

16. Addicted to alcohol and tobacco;

17. Take grapefruit or grapefruit product, drinks containing caffeine, xanthine and alcohol in 48 hours prior dosing;

18. The investigator believes that the subjects are not eligible to participate in this trial.

Related Conditions & MeSH terms

• NSCLC

Intervention

Drug:
• Apatinib Mesylate, Gefitinib
Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.

Locations

Country	Name	City	State
China	Sun Yat-Sen Univercity Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum Observed Plasma Concentration for apatinib	0-24 hours
Primary	AUC0-t	Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours	0-24 hours