A Randomized, Double-blind, Placebo-controlled, Multi-centre 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
- Conditions
- ocally Advanced and/or metastatic renal carcinomaMedDRA version: 8.1Level: LLTClassification code 10050076
- Registration Number
- EUCTR2005-004078-25-AT
- Lead Sponsor
- GlaxoSmithKline Research & Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
1. Diagnosis of clear cell RCC that is predominantly clear cell histology.
2. Locally advanced RCC (defined as disease not amenable to curative surgery or radiation therapy) 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. Must have received a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC with documented disease progression or documented treatment discontinuation due to unacceptable toxicity.
Note: The first-line cytokine-based treatment can be interleukin-2 (IL-2) or interferon-alpha (INF-alpha) monotherapy, IL-2 in combination with INF-alpha, IL-2 and/or INF-alpha in combination with chemotherapy or hormonal therapy.
Note: Prior adjuvant or neo-adjuvant therapies are permitted excluding any agents that target VEGF or VEGF receptors. The adjuvant/neo-adjuvant therapies should not be considered as first-line systemic treatment for advanced RCC.
Exception 1: Patients who live in countries or regions where cytokine therapy is not approved or where there are barriers to the access of such therapies are eligible to participate without receiving a first-line cytokine-based systemic treatment for locally advanced or metastatic RCC.
Exception 2: Patients who live in countries or regions where IL-2 or INF-? has been approved for the treatment of advanced/metastatic RCC, however, these agents are generally not recognized by the local clinical community as a standard treatment for advanced/metastatic RCC, or where the physician and the patient have determined that the available cytokine therapies are not an acceptable therapeutic option.
Exception 3: Patients who have recurred following prior adjuvant or neo-adjuvant cytokine therapy for RCC are eligible to participate without receiving a first-line systemic treatment for locally advanced or metastatic RCC. These patients should be stratified as the first-line population (See section 4 of the protocol).
5. Male or female >=18 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
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
- Secondary Outcome Measures
Name Time Method