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

NCT00387764 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-01-14

Study results available
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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.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

pazopanib

800 mg daily dosing continously until progression

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-12-31
Completion
2012-10-31

Countries

  • Argentina
  • Australia
  • Austria
  • Brazil
  • Chile
  • China
  • Czechia
  • Estonia
  • Italy
  • Latvia
  • Lithuania
  • New Zealand
  • Pakistan
  • Poland
  • Russia
  • Slovakia
  • South Korea
  • Tunisia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00387764 on ClinicalTrials.gov