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

Not Applicable

• Conditions: Soft tissue sarcoma

• Registration Number: JPRN-UMIN000016425
• Lead Sponsor: Showa University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-02
• Study Completion: 2021-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the pharmacokinetic factors that is associated with toxicity induced by pazopanib