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

Study Overview
=================
Brief 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.

Detailed 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.

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

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Sunitinib malate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunitinib<br>Sunitinib malate, 12.5mg/capsule, 50mg/day | Drug: Sunitinib malate<br>* Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.<br>* Other names: Sutent;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events (safety and tolerability) | To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | to evaluate the best response rate of sunitinib 2/1 schedule | 24 months | 
| progression free survival (PFS) | to evaluate the progression-free survival of sunitinib 2/1 schedule | 24 months | 
| patient reported outcome (PRO) | to evaluate the change of quality of life with sunitinib 2/1 schedule | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sunitinib, 2/1 schedule, Renal cell carcinoma