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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-12

Study Completion Date

2018-01-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sunitinib

Sunitinib malate, 12.5mg/capsule, 50mg/day

Group Type EXPERIMENTAL

Sunitinib malate

Intervention Type DRUG

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

Interventions

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Sunitinib malate

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

Intervention Type DRUG

Other Intervention Names

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Sutent

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No