NCT04390984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

May 26, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

May 13, 2020

Last Update Submit

January 7, 2021

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL

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

Apatinib Mesylate, GefitinibDRUG

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

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age.
  • ECOG performance status: level 0\~1;
  • Anticipated life expectancy ≥ 12 weeks;
  • Lung cancer patients;
  • Major organs in good function;
  • 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;
  • Able to comprehend and willing to sign an informed consent form (ICF)

You may not qualify if:

  • History of drug allergy, or allergic to apatinib or gefitinib or ingredients;
  • Squamous cancer, small-cell lung cancer;
  • Symptomatic central nervous system (CNS) metastases
  • Hypertension and couldn't be controlled with medicine;
  • Coagulation disorders;
  • Clinical significant bleeding in 3 months prior dosing;
  • Had surgery in four weeks prior dosing;
  • Disease that affect drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
  • Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess in 6 months prior dosing;
  • Urine protein ≥++, and urine protein ≥1.0g in 24 hours;
  • Active infection and need antimicrobial treatments;
  • History of psychiatric substance abuse;
  • Take any clinical trial drugs within four weeks prior dosing;
  • Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A and CYP2D6;
  • Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen Univercity Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

  • Ma Y, Chen Q, Zhang Y, Xue J, Liu Q, Zhao Y, Yang Y, Huang Y, Fang W, Hou Z, Li S, Wang J, Zhang L, Zhao H. Pharmacokinetics, safety, tolerability, and feasibility of apatinib in combination with gefitinib in stage IIIB-IV EGFR-mutated non-squamous NSCLC: a drug-drug interaction study. Cancer Chemother Pharmacol. 2023 Nov;92(5):411-418. doi: 10.1007/s00280-023-04563-2. Epub 2023 Jul 31.

    PMID: 37518060DERIVED

MeSH Terms

Interventions

apatinibGefitinib

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Li Zhang

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuya Wang, Ph.D

CONTACT

13918749176wangyuya@hrglobe.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 18, 2020

Study Start

May 26, 2020

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations

CN(1)