Tracking Information
| Start Date ICMJE | September 2006 |
|---|---|
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE (submitted: January 17, 2008) | 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 |
| Original Primary Outcome Measures ICMJE (submitted: October 12, 2006) | Incidence, severity and causality of all adverse events (AE), serious adverse events (SAEs) and other safety parameters |
| Change History | Complete list of historical versions of study NCT00387764 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE (submitted: June 9, 2008) | 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 |
| Original Secondary Outcome Measures ICMJE (submitted: October 12, 2006) |
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Descriptive Information
| Brief Title ICMJE | Extension Study to VEG105192 to Assess Pazopanib in Patients With Advanced/Metastatic Renal Cell Cancer |
|---|---|
| Official Title ICMJE | An Open-Label Extension Study to Assess the Safety and Efficacy of Pazopanib in Subjects With Renal Cell Carcinoma Previously Enrolled on Protocol VEG105192 |
| Brief Summary | 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. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Condition ICMJE | Advanced Renal Cell Carcinoma |
| Intervention ICMJE | Drug: pazopanib Other Name: pazopanib |
Recruitment Information
| Estimated Enrollment ICMJE | 132 | ||||
|---|---|---|---|---|---|
| Estimated Completion Date | April 2009 | ||||
| Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Argentina, Australia, Brazil, Chile, China, Czech Republic, Estonia, Hong Kong, Italy, Korea, Republic of, Latvia, Lithuania, New Zealand, Pakistan, Poland, Russian Federation, Slovakia, Tunisia, Ukraine, United Kingdom |
Administrative Information
| NCT ID ICMJE | NCT00387764 | ||||
|---|---|---|---|---|---|
| Responsible Party | Study Director, GSK | ||||
| Study ID Numbers ICMJE | VEG107769 | ||||
| Study Sponsor ICMJE | GlaxoSmithKline | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | GlaxoSmithKline |