Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer


Tracking Information

Start Date  ICMJESeptember 2006
Estimated Primary Completion DateApril 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: January 17, 2008)
Incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter
Original Primary Outcome Measures  ICMJE 
 (submitted: October 12, 2006)
Incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters
Change HistoryComplete list of historical versions of study NCT00387764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 9, 2008)
Response rate Progression free survival Overall survival Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter
Original Secondary Outcome Measures  ICMJE 
 (submitted: October 12, 2006)
  • Response rate
  • Progression free survival
  • Overall survival

Descriptive Information

Brief Title  ICMJEExtension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer
Official Title  ICMJEAn Open-Label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects With Renal Cell Carcinoma Previously Enrolled on Protocol VEG105192
Brief Summary

This is an open-label, international, multi-center study designed to provide access to pazopanib for subjects who have been enrolled in the Phase III renal cell carcinoma study (VEG105192) and have progressed on placebo. Subjects will receive 800 mg pazopanib once daily. The study treatment will continue until subjects experience disease progression, unacceptable toxicity, withdrawal of consent, or death. The primary objective of the study is to evaluate the safety and tolerability of pazopanib for the treatment of renal cell carcinoma. The secondary objectives of the study are to assess response rate (defined as complete response or partial response), progression-free survival, and overall survival. Response rates will be collected per investigator assessment (no central review). Subjects will have a CT/MRI scan every 6 weeks until week 24 and every 12 weeks thereafter.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJEAdvanced Renal Cell Carcinoma
Intervention  ICMJEDrug: pazopanib
Other Name: pazopanib

Recruitment Information

Estimated Enrollment  ICMJE132
Estimated Completion DateApril 2009
Estimated Primary Completion DateApril 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Progressed from VEG105192 study treatment
  • Patient's VEG105192 was placebo
  • Baseline has good organ function

Exclusion criteria:

  • No brain metastasis
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJEArgentina,   Australia,   Brazil,   Chile,   China,   Czech Republic,   Estonia,   Hong Kong,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   New Zealand,   Pakistan,   Poland,   Russian Federation,   Slovakia,   Tunisia,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00387764
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJEVEG107769
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical Trials, MDGlaxoSmithKline
Information Provided ByGlaxoSmithKline