The assessment of factor affecting toxicity of multikinase inhibitor pazopanib in soft tissue sarcoma

The assessment of factor affecting toxicity of multikinase inhibitor pazopanib in soft tissue sarcoma - The assessment of factor affecting toxicity of pazopanib in soft tissue sarcoma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016425

Enrollment

100

Registered

2015-02-02

Start date

2014-11-01

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

Soft tissue sarcoma

Interventions

Pazopanib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically confirmed soft tissue sarcoma 2) Unresectable advanced or recurrent disease 3) Age is over 20 years. 4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) is 0 to 2. 5) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy. Absolute neutrophil count>1,500/mm3 Platelet count<100,000/mm3 Hemoglobin<9.0g/dl Total bilirubin<2.0mg/dl AST and ALT<2.5 times the upper limit of normal(ULN) Creatinine<1.5mg/dl 6) Left ventricular ejection fraction (LVEF) in cardiac ultrasonography is over 50%. 7) QT interval time in electrocardiogram is under 480msec. 8) Blood pressure is under 150/90mmHg. If the patient receives the therapy for hypertension, blood pressure is controlled under 150/90mmHg by hypotensive drug. 9) Signed, written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) Interstitial pneumonia, pulmonary fibrosis 2) Severe active infection 3) Serological positive for HBs-antigen or HCV-antibody 4) Previous therapy with pazopanib 5) Unstable angina or myocardial infarction within 3 months 6) Thrombosis (e.g., cerebral infarction, pulmonary infarction, deep venous thrombosis)within 6 months 7) Peptic ulcer within 6 months 8) Surgery within 28 days 9) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease) 10) Active synchronous cancer 11) Severe psychiatric disorder 12) Pregnant or lactating women, or men and women without wanting pregnancy 13) Severe hypersensitivity to medicine 14) Taking medicine (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide) affecting CYP3A4 within one week 15) Taking proton pump inhibitor or H2 blocker within one week 16) Patients who were judged inappropriate for the study

Design outcomes

Primary

Measure	Time frame
To identify the pharmacokinetic factors that is associated with toxicity induced by pazopanib	—

Countries

Japan

Contacts

Public ContactHiroo Ishida

Showa University School of Medicine Division of Medical Oncology, Department of Medicine

hishida@med.showa-u.ac.jp03-3784-8000

Outcome results

None listed

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