Renal Cell Carcinoma
Conditions
Keywords
Sunitinib, 2/1 schedule, Renal cell carcinoma
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.
Interventions
DRUGSunitinib malate
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Sponsors
vghtpe user
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | 24 months | To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 24 months | to evaluate the best response rate of sunitinib 2/1 schedule |
| progression free survival (PFS) | 24 months | to evaluate the progression-free survival of sunitinib 2/1 schedule |
| patient reported outcome (PRO) | 24 months | to evaluate the change of quality of life with sunitinib 2/1 schedule |
Other
| Measure | Time frame | Description |
|---|---|---|
| single nuclear polymorphism | 24 months | to explore the relationship between select SNP associated with sunitinib 2/1 schedule |
Countries
Taiwan
Outcome results
None listed