CClinicalTrials.gg
Status unknownNCT04390984Updated Jan 11, 2021

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

A Phase 1 interventional study of Apatinib Mesylate, Gefitinib in NSCLC, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • NSCLC
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • 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

Interventions

  • DrugApatinib Mesylate, Gefitinib

    Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum Observed Plasma Concentration for apatinib

    Time frame: 0-24 hours

  2. AUC0-τ

    Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours

    Time frame: 0-24 hours

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-Sen Univercity Cancer Center
    Guangzhou, Guangdong 510060, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04390984
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
May 18, 2020
Start date
May 26, 2020
Primary completion
Feb 2021 (estimated)
Completion
Mar 2021 (estimated)
Last update
Jan 11, 2021

Study contacts

Yuya Wang, Ph.D
Contact
wangyuya@hrglobe.cn
13918749176
Li Zhang
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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