Overview

This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatment pazopanib
Phase phase 1
Targets VEGF, KIT, PDGF
Sponsor Novartis
Start date June 2006
End date February 2013
Trial size 200 participants
Trial identifier NCT00387205, VEG105430

Summary

This study is 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications
pazopanib
Pazopanib monotherapy or in combination with lapatinib or other approved anti-cancer medications

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in August 2016.