Study To Assess Long Term Safety Of Pazopanib

Novartis

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Pazopanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00387205

2006-005528-17 (EudraCT Number)

VEG105430

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

188 participants in 1 patient group

Arm 1

Experimental group

Description:

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

Treatment:

Drug: Pazopanib