NCT04390984

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-05-26
• Primary completion: 2021-02-01
• Completion: 2021-03-01
• First posted: 2020-05-18
• Last updated: 2021-01-11

Locations

1 site across 1 country: China