Clinical trial NCT04390984: Drug-drug Interaction Study of Gefitinb on Apatinib in NSCLC Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: NSCLC
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-05-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All the subjects will administrated with apatinib and gefitinib following the same sequence to assess the effect of gefitinib on the pharmacokinetics of apatinib in NSCLC patients
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax
timeFrame: 0-24 hours
measure: AUC0-τ
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Univercity Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Li Zhang
role: PRINCIPAL_INVESTIGATOR
References: