A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
Overview
- Phase
- Phase 2
- Intervention
- Sunitinib malate
- Conditions
- Renal Cell Carcinoma
- Sponsor
- vghtpe user
- Enrollment
- 13
- Locations
- 7
- Primary Endpoint
- Incidence of treatment-emergent adverse events (safety and tolerability)
- Status
- Terminated
- Last Updated
- 7 years ago
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.
Investigators
vghtpe user
Chief, Division of General Urology, Department of Urology
Taipei Veterans General Hospital, Taiwan
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
- •Allergic history to sunitinib
Arms & Interventions
Sunitinib
Sunitinib malate, 12.5mg/capsule, 50mg/day
Intervention: Sunitinib malate
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events (safety and tolerability)
Time Frame: 24 months
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
Secondary Outcomes
- Objective Response Rate (ORR)(24 months)
- progression free survival (PFS)(24 months)
- patient reported outcome (PRO)(24 months)