The exploratory study to determine optimum dosing of Axitinib (tyrosine kinase inhibitor) with pharmacokinetic analysis for patients with metastatic renal cell carcinoma

The exploratory study to determine optimum dosing of Axitinib (tyrosine kinase inhibitor) with pharmacokinetic analysis for patients with metastatic renal cell carcinoma - The study to determine optimum dosing of Axitinib for patients with metastatic renal cell carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011147

Enrollment

Registered

2013-07-10

Start date

2013-08-01

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

metastatic renal cell carcinoma

Interventions

We discriminate slow metabolizer or rapid metabolizer of Axitinib after we analyze the 15 cases,. On the basis of date, we escalate the dose of Axitinib in next 5 patients.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: metastatic rena cell carcinoma

Exclusion criteria

Exclusion criteria: 1) ECOG PS>1 2) sBP>150mmHg or dBP>100mmHg 3) Hb<9.0g/dl 4) neutrophil count<1000/mm3 5) pletelet count<75000/mm3 6) AST/ALT>2.5 ULN 7) total bilirubin>1.5 ULN 8) urine protein>2+ and 2g/day 9) sCre>1.5 ULN

Design outcomes

Primary

Measure	Time frame
The relationship between the blood concentration of Axitinib and the dosage amount, and to evaluate the association with clinical efficacy/adverse event and blood level.	—

Secondary

Measure	Time frame
The impact of the selected single nucleotide polymorphisms in CYP3A4 and UGT1A genes on the pharmacokinetics of Axitinib. The formulation of model that predict clinical effect and adverse event.	—

Countries

Japan

Outcome results

None listed

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