Study To Assess Long Term Safety Of Pazopanib

NCT ID: NCT00387205

Last Updated: 2019-03-06

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-20

Study Completion Date

2018-03-08

Brief Summary

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This study was a rollover study to evaluate the long term safety of pazopanib and to continue to provide pazopanib to patients who participated in a GSK sponsored pazopanib study until pazopanib is available commercially.

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Group Type EXPERIMENTAL

Pazopanib

Intervention Type DRUG

Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Interventions

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Pazopanib

Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participated or completed a GSK sponsored pazopanib study and remains eligible for continued treatment with pazopanib and lapatinib (if on combination therapy).
* Able to understand and provide written informed consent
* Women and men agree to use protocol specific birth control measures

Exclusion Criteria

* The subject has a treatment related serious adverse event that remains unresolved or unstable or had pazopanib permanently stopped in a previous study because of intolerate or because it was unsuccessful in treating your cancer
* If you are pregnant or breast feeding
* Your doctor does not think you would be a good candidate for the study
* Poorly controlled high blood pressure
* Subject is unwilling or unable to follow the procedures outlined in the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Duarte, California, United States

Site Status

Novartis Investigative Site

Santa Monica, California, United States

Site Status

Novartis Investigative Site

Aurora, Colorado, United States

Site Status

Novartis Investigative Site

Indianapolis, Indiana, United States

Site Status

Novartis Investigative Site

Detroit, Michigan, United States

Site Status

Novartis Investigative Site

Minneapolis, Minnesota, United States

Site Status

Novartis Investigative Site

Lebanon, New Hampshire, United States

Site Status

Novartis Investigative Site

New Brunswick, New Jersey, United States

Site Status

Novartis Investigative Site

Buffalo, New York, United States

Site Status

Novartis Investigative Site

Durham, North Carolina, United States

Site Status

Novartis Investigative Site

Cleveland, Ohio, United States

Site Status

Novartis Investigative Site

Greenville, South Carolina, United States

Site Status

Novartis Investigative Site

Nashville, Tennessee, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

Tacoma, Washington, United States

Site Status

Novartis Investigative Site

Lyon, , France

Site Status

Novartis Investigative Site

Singapore, , Singapore

Site Status

Novartis Investigative Site

Sutton, Surrey, United Kingdom

Site Status

Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

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United States France Singapore United Kingdom

Other Identifiers

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2006-005528-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VEG105430

Identifier Type: -

Identifier Source: org_study_id

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