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Safety and Efficacy of GW786034 (Pazopanib) In Metastatic Renal Cell Carcinoma

NCT00334282 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 435

Last updated 2016-02-05

Study results available
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Summary

To evaluate efficacy and safety of pazopanib compared to placebo in patients with locally advanced and/ or metastatic renal cell carcinoma (RCC). Approximately 350-400 eligible patients will be stratified and randomized in a 2:1 ratio to receive either 800 mg pazopanib once daily or matching placebo. The study treatment will continue until patients experience disease progression, unacceptable toxicity or death. Primary objective of the study is to evaluate and compare the two treatment arms for progression-free survival. Principal secondary objective is to evaluate and compare the two treatment arms with respect to overall survival. Other objectives are overall response rate \[complete response (CR) + partial response (PR)\], rate of CR + PR + 6 months stable disease, and the incidence, severity and causality of adverse events and serious adverse events. Safety and efficacy assessments will be regularly performed on all patients. An Independent Data Monitoring Committee will be established to monitor safety during the course of the study and to evaluate interim efficacy data on overall survival.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Pazopanib

Oral pazopanib tablet 800 mg once daily continuously

DRUG

placebo

matching placebo (800 mg tablet) once daily

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-05-31
Completion
2014-12-31

Countries

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

Study Locations

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Entities

Drugs
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 NCT00334282 on ClinicalTrials.gov