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

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

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.

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: Apatinib Mesylate, Gefitinib

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yuya Wang, Ph.D; Phone Number: 13918749176; Email: wangyuya@hrglobe.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-Sen Univercity Cancer Center
      • Contact: Li Zhang; Phone Number: 86-020-87343458; Email: Zhangli6@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Gefitinib; Apatinib
• Other Study ID Numbers: HR-APTN-DDI-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No