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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00158782
The ClinicalTrials.gov registry entry for NCT00158782 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lapatinib is the first listed.
NCT00158782 reports 0 study locations.
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.
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