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NCT00089999 · ClinicalTrials.gov registry record · Phase 2
Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer
A Phase 2 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 138
- Enrollment target
- 20
- Study locations
NCT00089999: Completed Phase 2 study of Neoplasms, Breast, sponsored by GlaxoSmithKline.
NCT00089999 is a Phase 2 study of Neoplasms, Breast that has completed, run by GlaxoSmithKline. The registered enrollment target is 138 participants, below the 1,053-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089999, a Phase 2 study of Neoplasms, Breast, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 138 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.
Primary Outcome
OR is defined as the number of participants achieving either a confirmed CR or PR, per Response Evaluation Criteria in Solid Tumors (RECIST, v 1.0). Best OR is defined as the best response recorded from the start of treatment until progressive disease (PD)/recurrence. CR is defined as the disappearance of all target lesions (TLs) and non-TLs. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of TLs, taking as a reference the Baseline sum LD and no PD, or complete
Conditions Studied
Interventions
- DRUG Lapatinib
Study Locations (20)
Other
- GSK Investigational Site - Pokfulam
- GSK Investigational Site - Delhi
- GSK Investigational Site - Hyderabad, Andhra Pradesh
- GSK Investigational Site - Pune
- GSK Investigational Site - Bandar Tun Razak, Cheras
- GSK Investigational Site - Kubang Kerian
- GSK Investigational Site - Tanjong Bungah
- GSK Investigational Site - Tanjong Bungah
- GSK Investigational Site - México
- GSK Investigational Site - Karachi
- GSK Investigational Site - Karachi
- GSK Investigational Site - Karachi
- GSK Investigational Site - Lahore
- GSK Investigational Site - Rawalpindi
Región Metro de Santiago
- GSK Investigational Site - Santiago
- GSK Investigational Site - Santiago
- GSK Investigational Site - Santiago
Florida
- GSK Investigational Site - Hollywood
Oaxaca
- GSK Investigational Site - Ixtaltepec / Espinal
Yucatán
- GSK Investigational Site - Mérida
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2004-06 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
What the finished NCT00089999 record still lists
NCT00089999 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 1,053-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 1 intervention - of which Lapatinib is the first listed.
NCT00089999 names 20 study sites across 5 states, led by Other, Región Metro de Santiago, Florida.
Frequently Asked Questions
What is clinical trial NCT00089999 about?
NCT00089999 is a clinical study titled "Lapatinib In Chemotherapy-Naive Or Metastatic Breast Cancer". This phase II study will evaluate and compare the efficacy and tolerability of two dose schedules (1500 mg QD and 500 mg BID) of oral Lapatinib as treatment for patients with advanced or metastatic breast cancer.
What is the current status of trial NCT00089999?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 138 participants. The study started on 2004-06. Estimated completion is 2008-03.
What conditions does trial NCT00089999 study?
This clinical trial studies the following conditions: Neoplasms, Breast.
What interventions are being tested in trial NCT00089999?
The interventions under investigation include: Lapatinib (DRUG).
Who is sponsoring clinical trial NCT00089999?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00089999 being conducted?
This trial has 20 study locations across Florida, Región Metro de Santiago, Oaxaca, Yucatán. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00089999's enrollment target sits among peer trials
138 4th of 9 higher than 6 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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