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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: Clinical Trial Phase 2 study, sponsored by GlaxoSmithKline.
NCT00709618 is a Phase 2 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions \[TLs\]) or partial response (PR: a \>=30% decrease in the sum of the longest diameter \[LD\] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a \>=20% increase in the sum of the LD of TLs, taking as a referen
Interventions
- DRUG Lapatinib, Vinorelbine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2008-06 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
Why NCT00709618 stopped before completion
NCT00709618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Lapatinib, Vinorelbine is the first listed.
NCT00709618 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00709618's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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