A Phase 2 interventional study of Sunitinib malate in Renal Cell Carcinoma, sponsored by vghtpe user. Terminated at 7 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by vghtpe user · Phase 2, Interventional, and Treatment
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 13 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →vghtpe user is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sunitinib malate, 12.5mg/capsule, 50mg/day
Drug: Sunitinib malate
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Also known as: Sutent
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
Time frame: 24 months
Objective Response Rate (ORR)
to evaluate the best response rate of sunitinib 2/1 schedule
Time frame: 24 months
progression free survival (PFS)
to evaluate the progression-free survival of sunitinib 2/1 schedule
Time frame: 24 months
patient reported outcome (PRO)
to evaluate the change of quality of life with sunitinib 2/1 schedule
Time frame: 24 months
single nuclear polymorphism
to explore the relationship between select SNP associated with sunitinib 2/1 schedule
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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