- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02626754
A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population
June 21, 2018 updated by: vghtpe user
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 81362
- Kaohsiung Veterans General Hospital
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Kaohsiung, Taiwan, 80756
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Taichung, Taiwan, 40705
- Taichung Veterans General Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Taipei, Taiwan, 11217
- Taipei Vterans General Hospital
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Taoyuan City, Taiwan, 333
- Chang Gung Memorial Hospital, Linkou
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sunitinib
Sunitinib malate, 12.5mg/capsule, 50mg/day
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Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-emergent adverse events (safety and tolerability)
Time Frame: 24 months
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To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
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24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: 24 months
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to evaluate the best response rate of sunitinib 2/1 schedule
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24 months
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progression free survival (PFS)
Time Frame: 24 months
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to evaluate the progression-free survival of sunitinib 2/1 schedule
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24 months
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patient reported outcome (PRO)
Time Frame: 24 months
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to evaluate the change of quality of life with sunitinib 2/1 schedule
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24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
single nuclear polymorphism
Time Frame: 24 months
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to explore the relationship between select SNP associated with sunitinib 2/1 schedule
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yen-Hwa Chang, M.D. Ph.D., Taipei Veterans General Hospital, Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 12, 2015
Primary Completion (Actual)
January 2, 2018
Study Completion (Actual)
January 2, 2018
Study Registration Dates
First Submitted
December 1, 2015
First Submitted That Met QC Criteria
December 7, 2015
First Posted (Estimate)
December 10, 2015
Study Record Updates
Last Update Posted (Actual)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Sunitinib
Other Study ID Numbers
- 2014-10-002A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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