A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinib

A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of afatinib - PK analysis of anticancer agent for lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000014237

Enrollment

200

Registered

2014-06-25

Start date

2014-06-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

adenocarcinoma of the lung

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with adenocarcinoma of the lung 2. Patients taking afatinib 3. Signed informed consent prior to blood sampling for this study.

Exclusion criteria

Exclusion criteria: No exclusion criteria

Design outcomes

Primary

Measure	Time frame
To assess PK/PD based on plasma concentration of afatinib, as well as efficacy and safety.	—

Secondary

Measure	Time frame
To explore genetic polymorphisms relating to pharmacokinetics, efficacy, and safety of afatinib.	—

Countries

Japan

Contacts

Public ContactHideki Hayashi

Gifu Pharmaceutical University Laboratoly of Pharmacy Practice and Social Science

hayashih@gifu-pu.ac.jp058-230-8100(3614)

Outcome results