A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population

Renal Cell Carcinoma Clinical Trial

Official title:

A Prospective Study on Sunitinib as First Line Therapy for Advanced/Metastatic Renal Cell Carcinoma in Asian Population

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02626754
• Other study ID #: 2014-10-002A
• Status: Terminated
• Phase: Phase 2
• Start date: August 12, 2015
• Est. completion date: January 2, 2018

Study information

• Verified date: June 2018
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: January 2, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-HO Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Vterans General Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
vghtpe user

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	single nuclear polymorphism	to explore the relationship between select SNP associated with sunitinib 2/1 schedule	24 months
Primary	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	Objective Response Rate (ORR)	to evaluate the best response rate of sunitinib 2/1 schedule	24 months
Secondary	progression free survival (PFS)	to evaluate the progression-free survival of sunitinib 2/1 schedule	24 months
Secondary	patient reported outcome (PRO)	to evaluate the change of quality of life with sunitinib 2/1 schedule	24 months