A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population

• Status: Terminated
• Trial end date: 2018-01-02
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-national, phase II, single arm study to explore the safety/efficacy and potential biomarkers on sunitinib 2/1 schedule for Asian patients with advanced renal cell carcinoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: vghtpe user
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Advanced renal cell carcinoma with histology confirmation

• Grade III/IV AEs happen during first cycle of sunitinib 50mg/day 4 weeks on followed by 2 weeks of rest

• ECOG performance status 0 or 1

• Appropriate vital organ functions

Exclusion Criteria:

• Prior systemic treatment of mRCC

• Patients treated with any neoadjuvant or adjuvant systemic therapy

• Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided there is at least one measurable lesion that has not been irradiated

• Pregnant

• Allergic history to sunitinib