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NCT00347919 · ClinicalTrials.gov registry record · Phase 2
Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer
A Phase 2 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
- 20
- Study locations
NCT00347919: Completed Phase 2 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
NCT00347919 is a Phase 2 study of Neoplasms, Breast that has completed, run by GlaxoSmithKline. The registered enrollment target is 189 participants, below the 1,047-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00347919, a Phase 2 study of Neoplasms, Breast, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.
Primary Outcome
The percentage of participants with progressive disease (PD) 12 weeks after randomization was measured. Per Response Evaluation Criteria In Solid Tumors (RECIST), a response of PD is defined as a \>=20% increase in target lesions. Participants were also classified as having PD if their response at Week 12 was unknown or missing. Response was determined by an independent radiologist and by an investigator.
Conditions Studied
Interventions
- DRUG pazopanib (GW786034) 400 mg
- DRUG lapatinib (GW572016) 1500 mg
- DRUG lapatinib (GW572016) 1000 mg
- DRUG pazopanib (GW786034) 800 mg
Study Locations (20)
California
- GSK Investigational Site - Alhambra
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - Fullerton
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Northridge
- GSK Investigational Site - Oxnard
- GSK Investigational Site - Redondo Beach
- GSK Investigational Site - Santa Barbara
- GSK Investigational Site - Santa Maria
Texas
- GSK Investigational Site - Dallas
- GSK Investigational Site - Lubbock
- GSK Investigational Site - San Antonio
Arkansas
- GSK Investigational Site - Jonesboro
Indiana
- GSK Investigational Site - Indianapolis
Louisiana
- GSK Investigational Site - Metairie
Nevada
- GSK Investigational Site - Henderson
New York
- GSK Investigational Site - The Bronx
Ohio
- GSK Investigational Site - Akron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2006-07 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT00347919 record still lists
NCT00347919 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 1,047-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 4 interventions - of which pazopanib (GW786034) 400 mg is the first listed.
NCT00347919 names 20 study sites across 9 states, led by California, Texas, Arkansas.
Frequently Asked Questions
What is clinical trial NCT00347919 about?
NCT00347919 is a clinical study titled "Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Advanced Or Metastatic Breast Cancer". This study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with locally advanced or metastatic breast cancer whose tumors overexpress the ErbB2 protein.
What is the current status of trial NCT00347919?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2006-07. Estimated completion is 2015-03.
What conditions does trial NCT00347919 study?
This clinical trial studies the following conditions: Neoplasms, Breast.
What interventions are being tested in trial NCT00347919?
The interventions under investigation include: pazopanib (GW786034) 400 mg (DRUG), lapatinib (GW572016) 1500 mg (DRUG), lapatinib (GW572016) 1000 mg (DRUG), pazopanib (GW786034) 800 mg (DRUG).
Who is sponsoring clinical trial NCT00347919?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00347919 being conducted?
This trial has 20 study locations across Arkansas, California, Indiana, Louisiana, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms, Breast
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00347919's enrollment target sits among peer trials
189 3rd of 9 higher than 7 of 9 other Neoplasms, Breast trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms, Breast 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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