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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00387764
First received: October 12, 2006
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Carcinoma, Renal Cell
 Drug: pazopanib
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects With Renal Cell Carcinoma Previously Enrolled on Protocol VEG105192

Resource links provided by NLM:

Drug Information available for: Pazopanib
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Enrollment: 132
Study Start Date: September 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pazopanib arm
This was a single arm study, therefore no control arm.
 Drug: pazopanib
800 mg daily dosing continously until progression
Other Name: pazopanib

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

  • No brain metastasis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387764

Locations
Argentina
GSK Investigational Site
Cordoba, Córdova, Argentina, 5000
GSK Investigational Site
Quilmes, Argentina, 1878
GSK Investigational Site
Tucuman, Argentina, 4000
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6021
Pakistan
GSK Investigational Site
Karachi, Pakistan, 74800
GSK Investigational Site
Lahore, Pakistan, 54600
Tunisia
GSK Investigational Site
Tunis, Tunisia, 1008
GSK Investigational Site
Tunis, Tunisia, 1007
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00387764     History of Changes
Other Study ID Numbers: VEG107769
Study First Received: October 12, 2006
Last Updated: May 9, 2013
Health Authority: Austria: Ethikkommission
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
renal cell carcinoma
pazopanib
anti-angiogenic therapy
open label

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013