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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 158 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00996762
The ClinicalTrials.gov registry entry for NCT00996762 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 158 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 1 intervention - of which lapatinib is the first listed.
NCT00996762 reports 0 study locations.
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.
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