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NCT01328054 · ClinicalTrials.gov registry record · Phase 4
A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 58
- Enrollment target
NCT01328054: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01328054 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 58 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328054, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 58 participants
- Enrollment target
Study Summary
This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval duration) in subjects with advanced solid tumors. The study treatment period will occur over five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days beyond Day 8). Subjects will receive placebo that mimics lapatinib for 2 days as three separate doses given 12 hours apart (8 tablets/dose) and lapatinib (2000mg) for 2 days as three separate doses given 12 hours apart (8 tablets/dose). Subjects will not know when they are receiving placebo vs. lapatinib. Digital 12-lead ECG recordings will be extracted from continuous ECG recordings obtained via a Holter monitor to measure QTc interval duration. Triplicate ECG measurements of QTc interval will be taken at pre-specified times at Day 1 (Baseline) and pre-dose and up to 24 hours after the third dose of placebo or lapatinib on Study Days 2 and 4. Pharmacokinetic sampling will occur immediately following each pre-specified QTc measurement in subjects dosed with placebo or lapatinib. Subjects who complete participation in this study, if they are eligible, will be offered the option to continue treatment with lapatinib, either alone or in combination with other oncology drugs in pre-selected anticancer regimens, in a continuation protocol, EGF111767.
Primary Outcome
A Holter monitor is an ambulatory portable device used for continuously monitoring the cardiovascular system. Three replicate electrocardiograms (ECGs) were collected at 30, 15, and 0 minutes prior to the administration of study treatment (trt) on Days 1 and 3 and pre-dose, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hr post-dose on Days 2 and 4. The 3 readings at each time point (TP) were averaged prior to any analysis. BL is the average of the pre-dose QTcF values (triplicate) taken on Day 1 for PBO and
Interventions
- DRUG lapatinib
- DRUG placebo matching lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2011-12 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT01328054 record still lists
NCT01328054 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which lapatinib is the first listed.
NCT01328054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328054 about?
NCT01328054 is a clinical study titled "A Study in Cancer Patients to Evaluate the Effect of Lapatinib on the QTc Interval". This study will estimate the effect of lapatinib on cardiac repolarization (QTc interval duration) in subjects with advanced solid tumors. The study treatment period will occur over five days and an End of Study visit will be conducted on Day 8 (or no later than 3 days beyond Day 8). Subjects will r...
What is the current status of trial NCT01328054?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 58 participants. The study started on 2011-12. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01328054?
The interventions under investigation include: lapatinib (DRUG), placebo matching lapatinib (DRUG).
Who is sponsoring clinical trial NCT01328054?
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 NCT01328054's enrollment target sits among peer trials
58 1205th of 2000 higher than 792 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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