SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-03-31

Brief Summary

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The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.

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Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol

Interventions

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Sunitinib

50 mg orally daily for 4 weeks followed by 2 weeks off treatment for approximately 1 year or until disease progression/unacceptable toxicity; after completion of 1 year, pts with clinical benefit can continue the study treatment in a separate continuation protocol

Intervention Type DRUG

Other Intervention Names

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SUTENT, SU011248,

Eligibility Criteria

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Inclusion Criteria

* Histologically proven renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease
* Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
* Prior radical or partial nephrectomy

Exclusion Criteria

* Prior treatment with any other anti-angiogenic therapy other than bevacizumab
* Prior systemic treatment for RCC \> 2 regimens
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No