Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer

NCT ID: NCT00387764

Last Updated: 2014-01-14

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2012-10-31

Brief Summary

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This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.

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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pazopanib arm

This was a single arm study, therefore no control arm.

Group Type EXPERIMENTAL

pazopanib

Intervention Type DRUG

800 mg daily dosing continously until progression

Interventions

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pazopanib

800 mg daily dosing continously until progression

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Progressed from VEG105192 study treatment
* Patient's VEG105192 was placebo
* Baseline has good organ function

Exclusion Criteria

* No brain metastasis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Capital Federal, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Quilmes, , Argentina

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San Miguel de Tucumán, , Argentina

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Waratah, New South Wales, Australia

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Hobart, Tasmania, Australia

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Heidelberg, Victoria, Australia

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Salzburg, , Austria

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Vienna, , Austria

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Belo Horizonte, Minas Gerais, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Región Metro de Santiago, Chile

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Beijing, , China

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Beijing, , China

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Brno, , Czechia

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Chomutov, , Czechia

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Prague, , Czechia

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Tartu, , Estonia

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Christchurch, , New Zealand

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Wellington, , New Zealand

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Karachi, , Pakistan

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Lahore, , Pakistan

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Gdansk, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Olsztyn, , Poland

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Chelyabinsk, , Russia

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Kazan', , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Bratislava, , Slovakia

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Seoul, , South Korea

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Seoul, , South Korea

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Songpa-gu, Seoul, , South Korea

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Sfax, , Tunisia

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Sousse, , Tunisia

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Tunis, , Tunisia

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Tunis, , Tunisia

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Bebington, Wirral, , United Kingdom

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Belfast, Northern Ireland, , United Kingdom

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Manchester, , United Kingdom

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Countries

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Argentina Australia Austria Brazil Chile China Czechia Estonia Italy Latvia Lithuania New Zealand Pakistan Poland Russia Slovakia South Korea Tunisia Ukraine United Kingdom

Other Identifiers

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VEG107769

Identifier Type: -

Identifier Source: org_study_id

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