Renal Cell Carcinoma MedDRA version: 8.1 Level: LLT Classification code 10038415 Term: Renal cell carcinoma stage unspecified
Conditions
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. Have been enrolled into study VEG105192 and have documented disease progression after being randomized into the placebo arm. 3. A woman is eligible to participate in the study if she is of: a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), as defined in the protocol). b. Childbearing potential, has a negative serum pregnancy test within 2 weeks of the first dose of pazopanib, and agrees to use adequate contraception. GSK acceptable contraceptive methods are defined in the protocol. 4. ECOG PS 0, 1, 2 5. Adequate baseline organ function at the baseline visit as defined in the protocol. 6. At least 4 weeks must have elapsed since the last surgery and 2 weeks must have elapsed since radiotherapy. 7. Complete recovery from prior surgery, and/or reduction of all AEs to Grade 1 from prior systemic therapy or radiotherapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female. 2. Malabsorption syndrome or disease that significantly affects gastrointestinal function, or major resection of the stomach or small bowel that could affect the absorption of pazopanib. 3. Symptomatic central nervous system (CNS) metastasis or leptomeningeal tumors. 4. Unable to swallow and retain orally administered medication. 5. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment. 6. History of human immunodeficiency virus infection. 7. Presence of uncontrolled infection. 8. Corrected QT interval (QTc) prolongation at baseline defined as QTc interval > 470 msecs. 9. History of Class III or IV congestive heart failure according to New York Heart Association (NYHA) classification [See Section 12.3 Appendix 3 for description]. 10. History of any of the cardiac conditions lsited in the protocol within the past 6 months. 11. History of cerebrovascular accident or pulmonary embolus within the past 6 months. 12. Poorly controlled hypertension at baseline [as defined in the protocol]. 13. History of untreated deep venous thrombosis (DVT) within the past 6 months. 14. Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease. 15. Evidence of bleeding diathesis or coagulopathy. 16. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance to the study. 17. Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of pazopanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the objective response rate (Complete Response [CR] + Partial Response [PR]) of subjects treated with pazopanib. To evaluate CR + PR + 6-months stable disease (SD) in subjects treated with pazopanib. To evaluate Progression Free Survivial (PFS) To evaluate overall survival (OS) in subjects treated with pazopanib 800mg. ;Primary end point(s): Safety of 800 mg pazopanib administered to subjects with renal cell carcinoma;Main Objective: To evaluate the safety and tolerability of pazopanib 800 mg daily dosing (QD) in patients with advanced /metastatic (RCC) which includes the incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters. | — |
Countries
Austria, Czech Republic, Estonia, Greece, Ireland, Italy, Latvia, Lithuania, United Kingdom
Outcome results
None listed