Study To Assess Long Term Safety Of Pazopanib

Novartis Pharmaceuticals188 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

188

Conditions

Carcinoma, Renal Cell

Interventions

PazopanibDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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 Key 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.

Locations (19)

Novartis Investigative Site

Duarte, California, United States

Novartis Investigative Site

Santa Monica, California, United States

Outcomes

Primary Outcomes

To evaluate the long-term safety of repeat daily doses of pazopanib in cancer subjects with solid tumors

To evaluate the safety assessments; adverse events, vital signs, physical examinations, electrocardiograms, multi-gated acquisition scans or echocardiograms (only for patients on pazopanib and lapatinib combination therapy), and clinical laboratory assessments.

Time frame: Subjects will stay on the study as long as they are benefiting from treatment, have not met one of the stopping criteria, or experienced a toxicity up to 72 months.

Data from ClinicalTrials.gov

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