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NCT00158782 · ClinicalTrials.gov registry record · Phase 1
Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT00158782: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00158782 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00158782, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The study first will find the best doses using safety and blood concentration data of both agents. This is done enrolling stepwise, cohorts of 3 patients each and the last patient enrolled must reach at least Day 22 of continuous daily dosing before the next cohort at an increased dose can begin. If a patient in a cohort has a dose limiting toxicity before Day 22, then 3 more patients are studied at that same dose. If 2 of 6 patients have dose limiting toxicities within the first 22 days, the next cohort receives the next lowest dose. Otherwise each cohort has an increasing dose of one of the two agents. The second stage of the study will administer the best doses of the agents to about 16 patients to further study safety and collect more blood concentration data (more blood samples in the second phase compared to the first phase). The second stage has the advantage of using the best dose (decreases chance of receiving a sub-therapeutic dose) while it collects more blood samples and requires slightly more long clinic visits.
Interventions
- DRUG lapatinib
- DRUG GW786034
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-09-28 |
| Est. Completion | 2007-08-21 |
| Phase | Phase 1 |
What the finished NCT00158782 record still lists
NCT00158782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which lapatinib is the first listed.
NCT00158782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00158782 about?
NCT00158782 is a clinical study titled "Study Of Safety And Tolerability Of GW786034 Given With Lapatinib In Cancer Patients". This Phase I, dose finding study evaluates the safety and tolerability of lapatinib, a dual tyrosine kinase inhibitor, and GW786034, an anti-angiogenesis agent, when given together. The study first will find the best doses using safety and blood concentration data of both agents. This is done enroll...
What is the current status of trial NCT00158782?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2004-09-28. Estimated completion is 2007-08-21.
What interventions are being tested in trial NCT00158782?
The interventions under investigation include: lapatinib (DRUG), GW786034 (DRUG).
Who is sponsoring clinical trial NCT00158782?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00158782's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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