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

Status

Terminated

Intervention / Treatment

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

      • Kaohsiung, Taiwan, 81362
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11490
        • Tri-Service General Hospital
      • Taipei, Taiwan, 11217
        • Taipei Vterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou

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
Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
Other Names:
  • Sutent

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
To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 24 months
to evaluate the best response rate of sunitinib 2/1 schedule
24 months
progression free survival (PFS)
Time Frame: 24 months
to evaluate the progression-free survival of sunitinib 2/1 schedule
24 months
patient reported outcome (PRO)
Time Frame: 24 months
to evaluate the change of quality of life with sunitinib 2/1 schedule
24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
single nuclear polymorphism
Time Frame: 24 months
to explore the relationship between select SNP associated with sunitinib 2/1 schedule
24 months

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

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.

Clinical Trials on Renal Cell Carcinoma

Clinical Trials on Sunitinib malate

Subscribe