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

Phase 2

Terminated

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: Sunitinib malate

• Registration Number: NCT02626754
• Lead Sponsor: vghtpe user

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.

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 Timeline

• Study Start: 2015-08-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Primary Completion: 2018-01-02
• Study Completion: 2018-01-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunitinib	Sunitinib malate	Sunitinib malate, 12.5mg/capsule, 50mg/day

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (safety and tolerability)	24 months	To evaluate the safety and tolerance of sunitinib two weeks on, one week off for advanced renal cell carcinoma

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Taipei Vterans General Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou; 🇨🇳 Taoyuan City, Taiwan

Kaohsiung Medical University Chung-HO Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan