Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma

Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of Japanese patients with metastatic renal cell carcinoma - Prospective multicenter trial on the identification of novel biomarkers for Sunitinib therapy in the treatment of metastatic renal cell carcinoma

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009622

Enrollment

Registered

2012-12-25

Start date

2009-11-01

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

renal cell carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Japanese patients older than 18. 2.Diagnosed as metastatic renal cell carcinoma with clear cell component. 3.No chemotherapy/radiation has been performed/ or No efficacy by cytokine treatment 4.Having evaluable disease by CT scan, which is regulated in RECIST. 5. Performance status (ECOG) 0-1 6. Maintaining vital organ functions 7. Survival period is expected more than 12 weeks 8. Informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1.brain metastasis 2.uncontrollable hypertention 3.Active or symptomatic angina pectoris or coronary artery disease (myocardial infarction within 12 months or symptomatic unstable angina), Symptomatic congestive heart failure, Long QTc 4.History of being allergic to Sunitinib 5.Pregnant or lactating woman, including the possibility of pregnant 6.Post organ transplantation, including hematopoietic stem cell transplantation 7.History of malignancy, excluding following cases Cervical cancer (carcinoma in situ), Basal cell carcinoma, Superficial bladder cancer(Ta, Tis and T1, which have been treated properly Malignancies treated radically more than 3 years before, without recurrence 8.History of VEGF/ VEGF-R targeted therapy 9.Systemic treatment with steroids 10.Interstitial pneumonia

Design outcomes

Primary

Measure	Time frame
inflammation markers IL-6, CRP, IL-8, hepcidin immunologic markers Th1/Th2 bias, TReg, MDSC angiogenesis markers VEGF-C, soluble VEGFR-2, soluble VEGFR-3, b-FGF	—

Secondary

Measure	Time frame
response rate, progression free survival, overall survival, safety	—

Countries

Japan

Contacts

Public ContactRyuichi Mizuno

Keio University School of Medicine Department of Urology

mizunor@z7.keio.jp03-5363-3825

Outcome results