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NCT00244764 · ClinicalTrials.gov registry record · Phase 2
GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma
A Phase 2 study of Carcinoma, Renal Cell, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT00244764: Completed Phase 2 study of Carcinoma, Renal Cell, sponsored by GlaxoSmithKline.
NCT00244764 is a Phase 2 study of Carcinoma, Renal Cell that has completed, run by GlaxoSmithKline. The registered enrollment target is 225 participants, below the 277-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00244764, a Phase 2 study of Carcinoma, Renal Cell, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an open label, single arm study with all subjects receiving pazopanib.
Primary Outcome
The overall response is the number of participants who experience a confirmed complete (CR) or partial response (PR) of the total analysis population. Per the Response Evaluation Criteria In Solid Tumors (RECIST): CR = all detectable tumor has disappeared, PR = a \>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum, Progressive disease (PD) = a \>=20% increase in target lesions, Stable Disease = small changes that do not meet previousl
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GW786034
Study Locations (20)
California
- GSK Investigational Site - Duarte
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Orange
- GSK Investigational Site - San Francisco
Victoria
- GSK Investigational Site - East Melbourne
- GSK Investigational Site - Footscay
- GSK Investigational Site - Heidelberg
- GSK Investigational Site - Parkville
New South Wales
- GSK Investigational Site - Camperdown
- GSK Investigational Site - Kogarah
- GSK Investigational Site - Randwick
Ohio
- GSK Investigational Site - Cleveland
- GSK Investigational Site - Cleveland
Colorado
- GSK Investigational Site - Aurora
Georgia
- GSK Investigational Site - Tucker
Indiana
- GSK Investigational Site - Indianapolis
New York
- GSK Investigational Site - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2005-10 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
What the finished NCT00244764 record still lists
NCT00244764 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 277-participant average among 34 other Carcinoma, Renal Cell trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Carcinoma, Renal Cell appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00244764 names 20 study sites across 11 states, led by California, Victoria, New South Wales.
Frequently Asked Questions
What is clinical trial NCT00244764 about?
NCT00244764 is a clinical study titled "GW786034 In Subjects With Locally Recurrent Or Metastatic Clear Cell Renal Cell Carcinoma". Phase II, multi-center, two-stage study utilising a randomised discontinuation design to evaluate the safety and efficacy of GW786034 (pazopanib) in adult subjects with locally recurrent or metastatic clear-cell Renal Cell Carcinoma (RCC). After the interim analysis, the design was changed to an ope...
What is the current status of trial NCT00244764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 225 participants. The study started on 2005-10. Estimated completion is 2013-09.
What conditions does trial NCT00244764 study?
This clinical trial studies the following conditions: Carcinoma, Renal Cell.
What interventions are being tested in trial NCT00244764?
The interventions under investigation include: Placebo (DRUG), GW786034 (DRUG).
Who is sponsoring clinical trial NCT00244764?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00244764 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00244764's enrollment target sits among peer trials
225 9th of 34 higher than 26 of 34 other Carcinoma, Renal Cell trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Renal Cell trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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