Study To Assess Long Term Safety Of Pazopanib

Carcinoma, Renal Cell Clinical Trial

Official title:

An Open-Label, Phase Ib Study to Assess the Long Term Safety Profile of Pazopanib in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00387205
• Other study ID #: VEG105430
• Secondary ID: 2006-005528-17
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2006
• Est. completion date: March 8, 2018

Study information

• Verified date: March 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: March 8, 2018
• Est. primary completion date: February 13, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

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

Locations

Country	Name	City	State
France	Novartis Investigative Site	Lyon Cedex 08
Singapore	Novartis Investigative Site	Singapore
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Sutton	Surrey
United States	Novartis Investigative Site	Aurora	Colorado
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Detroit	Michigan
United States	Novartis Investigative Site	Duarte	California
United States	Novartis Investigative Site	Durham	North Carolina
United States	Novartis Investigative Site	Greenville	South Carolina
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Lebanon	New Hampshire
United States	Novartis Investigative Site	Minneapolis	Minnesota
United States	Novartis Investigative Site	Nashville	Tennessee
United States	Novartis Investigative Site	New Brunswick	New Jersey
United States	Novartis Investigative Site	Santa Monica	California
United States	Novartis Investigative Site	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  France,  Singapore,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.

External Links

•   Results for VEG105430 from the Novartis Clinical Trials Website.