Study Stopped
In most sites had difficult to recruitting subjects.
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
1 other identifier
interventional
13
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2015
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 12, 2015
CompletedFirst Submitted
Initial submission to the registry
December 1, 2015
CompletedFirst Posted
Study publicly available on registry
December 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2018
CompletedJune 26, 2018
June 1, 2018
2.4 years
December 1, 2015
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Objective Response Rate (ORR)
24 months
progression free survival (PFS)
24 months
patient reported outcome (PRO)
24 months
Other Outcomes (1)
single nuclear polymorphism
24 months
Study Arms (1)
Sunitinib
EXPERIMENTALSunitinib malate, 12.5mg/capsule, 50mg/day
Interventions
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- vghtpe userlead
Study Sites (7)
Kaohsiung Medical University Chung-HO Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Vterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yen-Hwa Chang, M.D. Ph.D.
Taipei Veterans General Hospital, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief, Division of General Urology, Department of Urology
Study Record Dates
First Submitted
December 1, 2015
First Posted
December 10, 2015
Study Start
August 12, 2015
Primary Completion
January 2, 2018
Study Completion
January 2, 2018
Last Updated
June 26, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share