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

Phase 1

• Conditions: NSCLC
• Interventions: Drug: Apatinib Mesylate, Gefitinib

• Registration Number: NCT04390984
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Study Start: 2020-05-26
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-02
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	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.

Primary Outcome Measures

Name	Time	Method
Cmax	0-24 hours	Maximum Observed Plasma Concentration for apatinib
AUC0-τ	0-24 hours	Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours

Trial Locations

Locations (1)

Sun Yat-Sen Univercity Cancer Center; 🇨🇳 Guangzhou, Guangdong, China