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

Phase 2TerminatedNCT02626754

vghtpe user13 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Cell Carcinoma

Interventions

Sunitinib malateDRUG

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (7)

Kaohsiung Medical University Chung-HO Memorial Hospital

Kaohsiung City, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

Objective Response Rate (ORR)

to evaluate the best response rate of sunitinib 2/1 schedule

Time frame: 24 months

progression free survival (PFS)

to evaluate the progression-free survival of sunitinib 2/1 schedule

Time frame: 24 months

patient reported outcome (PRO)

to evaluate the change of quality of life with sunitinib 2/1 schedule

Time frame: 24 months

Data from ClinicalTrials.gov

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