Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib

Impact of gene polymorphism on the pharmacokinetics and the clinical response in patients with hepatocellular carcinoma using lenvatinib - Gene polymorphism and the pharmacokinetics and clinical response of lenvanib

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033300

Enrollment

Registered

2018-07-05

Start date

2018-07-06

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

Hepatocellular carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Performance Status 0 or 1 (ECOG) 2. Child-Pugh class A (score 5 or 6) 3. No past history of molecular targeting drugs including treatment of the other cancers. 4. Laboratory data fulfills all criteria as below 1) neutrophil count more than 1.5x109 /L 2) Hemogblobin more than 8.5 g/dL 3) Total bilirubin less than 2.0 mg/dL 4) Blood pressure less than 150/90 mmHg

Exclusion criteria

Exclusion criteria: 1. Patients regarded as inappropriate subject 2. Patients who lack of ability of judgement, despite fulfill the listed above

Design outcomes

Primary

Measure	Time frame
To clarify the relationship between the exposure of lenvatinib at the start of treatment and two week from the start of treatment and the gene polymorphisms of p-glycoprotein and breast cancer resistant protein.	—

Secondary

Measure	Time frame
1)To clarify the relationship between the exposure of lenvatinib and the clinical response 2)To examine relationship between plasma and urinary carnitine levels and extent of fatigue	—

Countries

Japan

Contacts

Public ContactHironao Okubo

Juntendo University Nerima Hospital Department of Gastroenterology

drokubo@juntendo-nerima.jp+81-3-5923-3111

Outcome results