Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC

Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib in patients with ALK fusion gene positive NSCLC - Multicenter study on the Pharmacokinetics and pharmacogenetics of crizotinib

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009846

Enrollment

100

Registered

2013-01-31

Start date

2013-02-01

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

ALK fusion gene positive NSCLC

Interventions

To evaluate steady state plasma concentration of Crizotinib and its metabolites. To analyse gene polymorphism. To evaluate plasma concentration of Crizotinib and its metabolites at the time of occur

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histlogically or cytologically confirmed ALK fusion gene positive NSCLC 2.Unresectable and metastatic NSCLC 3.The patient who is plan to receive Crizotinib therapy (250mg twice a day)

Exclusion criteria

Exclusion criteria: 1. Concomitant treatment with other anticancer agent, radiotherapy, or immunotherapy. 2. Preexisting interstitial lung disease

Design outcomes

Primary

Measure	Time frame
To evaluate the correlation polymorphisms of ABCB1 and CYP3A4/5 with steady state plasma concentration and adverse events of Crizotinib.	—

Countries

Japan

Contacts

Public ContactYutaka Fujiwara

National Cancer Center Hospital Thoracic Oncology

yutakafu@ncc.go.jp03-3542-2511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026