A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) Compared to Placebo in Patients with Locally Advanced and/or Metastatic Renal Cell Carcinoma Who Have Progressed Following Cytokine-based First-line Treatment

• Conditions: ocally Advanced and/or metastatic renal carcinoma; MedDRA version: 8.1Level: LLTClassification code 10050076

• Registration Number: EUCTR2005-004078-25-IE
• Lead Sponsor: GlaxoSmithKline Research & Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-05
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

1. Diagnosis of clear cell RCC that is predominantly clear cell histology.
2. Locally advanced and/or metastatic RCC (equivalent to Stage IV RCC according to AJCC staging
3. Must have measurable disease, i.e. presenting with at least one measurable lesion per RECIST. A measurable lesion is defined as a lesion that can be accurately measured in at least one dimension with the longest diameter >20 mm using conventional techniques, or >10 mm with spiral CT scan.
4. Documented disease progression (based on radiographic imaging) following a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC. The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-alpha (INF-alpha) monotherapy, or IL-2 or INF-alpha in combination with chemotherapy.
5. Male or female >21 years of age.
6. ECOG PS 0 or 1
7. Adequate baseline organ function as defined in the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of another malignancy.
2. History or presence of central nervous system (CNS) metastasis or leptomeningeal tumors as documented by CT or MRI scan, analysis of cerebrospinal fluid or neurological exam.
3. Presence of uncontrolled infection.
4. History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification [See 14.5 Appendix 5 of protocol for description].
5. Current or prior use of an investigational anti-cancer drug within 4 weeks of start of study.
6. Prior use of an investigational or licensed drug that targets VEGF or VEGF receptors (eg. bevacizumab, sunitinib, sorafinib, etc).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate and compare Progression Free Survival (PFS) of patients treated with pazopanib to those treated with placebo.;Secondary Objective: To compare Overall Survival (OS) of patients treated with pazopanib to those treated with placebo. <br>To compare overall response rate [ORR = complete response (CR) + partial response (PR)] in patients treated with pazopanib to those treated with placebo. <br>To compare the rate of CR + PR + 6-months stable disease (SD) in patients treated with pazopanib to those treated with placebo.<br>To assess the incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters in patients treated with pazopanib and placebo.<br>;Primary end point(s): Progression Free Survival defined as the interval between the date of randomization and the earliest date of disease progression (as defined by the independent reviewer) or death due to any cause.