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NCT00996762 · ClinicalTrials.gov registry record · Phase 1
A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 158
- Enrollment target
NCT00996762: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT00996762 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 158 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996762, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 158 participants
- Enrollment target
Study Summary
This study will assess alternative formulations of lapatinib for relative bioavailability and bioequivalence (BE) with the current commercial formulation (reference). Subjects will be dosed for at least one week (7 days) on each formulation and PK samples will be collected after each lapatinib formulation dosing Period on Period 1 Day 7 and Period 2 Day7 at pre-dose and up to 24 hrs post dose. The study may evaluate up to three alternative test formulations. After subjects complete the PK evaluation at the End of Study Visit, if they are eligible, they will have the option to enter EGF111767, an open-label, Phase Ib continuation study of lapatinib monotherapy or lapatinib in combination with other anti-cancer treatments.
Interventions
- DRUG lapatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2009-11-12 |
| Est. Completion | 2012-09-18 |
| Phase | Phase 1 |
What the finished NCT00996762 record still lists
NCT00996762 is an interventional study that assigns participants to a tested intervention. The registered 158 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 1 intervention - of which lapatinib is the first listed.
NCT00996762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00996762 about?
NCT00996762 is a clinical study titled "A Study in Cancer Patients to Evaluate the Bioequivalence of Alternative Formulations of Lapatinib". This study will assess alternative formulations of lapatinib for relative bioavailability and bioequivalence (BE) with the current commercial formulation (reference). Subjects will be dosed for at least one week (7 days) on each formulation and PK samples will be collected after each lapatinib formu...
What is the current status of trial NCT00996762?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 158 participants. The study started on 2009-11-12. Estimated completion is 2012-09-18.
What interventions are being tested in trial NCT00996762?
The interventions under investigation include: lapatinib (DRUG).
Who is sponsoring clinical trial NCT00996762?
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 NCT00996762's enrollment target sits among peer trials
158 348th of 2000 higher than 1,650 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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