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

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Status and phase

Terminated

Phase 2

Conditions

Renal Cell Carcinoma

Treatments

Drug: Sunitinib malate

Study type

Interventional

Funder types

Other

Identifiers

NCT02626754

2014-10-002A

Details and patient eligibility

About

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.

Full description

Sunitinib 50mg daily on 4/2 dose schedule has been established as standard of care (SOC) for advanced renal cell carcinoma (RCC). However, Asian patients in real world experienced grade III/IV adverse events much more than expected. This multi-national, phase II, single arm study is going to explore more on the safety/efficacy and relevant biomarkers on sunitinib 2/1 dose schedule in Asian people with advanced RCC.

Enrollment

13 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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