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NCT00709618 · ClinicalTrials.gov registry record · Phase 2
Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects
A Phase 2 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT00709618 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 44 participants.
The verdict
NCT00709618, a Phase 2 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
This is an open-label, single-arm, multi-center, Phase II study to determine the activity of vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study. Subjects will receive vinorelbine intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib daily. Subjects will receive treatment until disease progression or withdrawal from the study. The primary objective of this study is to evaluate overall tumor response rate of lapatinib in combination with vinorelbine. Secondary objectives include progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments will be performed at 4, 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line or Second-line therapy, Lapatinib, Vinorelbine
Interventions
- DRUG Lapatinib, Vinorelbine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00709618
The ClinicalTrials.gov registry entry for NCT00709618 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 44 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, Vinorelbine is the first listed.
NCT00709618 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00709618 about?
NCT00709618 is a clinical study titled "Lapatinib + Vinorelbine in ErbB2 Overexpressing, First or Second Line Metastatic Breast Cancer Subjects". This is an open-label, single-arm, multi-center, Phase II study to determine the activity of vinorelbine plus lapatinib in either first- or second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects will be enrolled in the study. Subjects will receive vinor...
What is the current status of trial NCT00709618?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2008-06. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00709618?
The interventions under investigation include: Lapatinib, Vinorelbine (DRUG).
Who is sponsoring clinical trial NCT00709618?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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