Study To Assess Long Term Safety Of Pazopanib

Phase 1

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Pazopanib

• Registration Number: NCT00387205
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-06-20
• Study First Submitted: 2006-10-10
• Study First Submitted QC: 2006-10-10
• Study First Posted: 2006-10-12
• Primary Completion: 2013-02-13
• Study Completion: 2018-03-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Pazopanib	Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Primary Outcome Measures

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Newcastle Upon Tyne, United Kingdom