CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Lapatinib +1 moredrug
Likely dose
Lapatinib 1250mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00477464
NCT00477464Phase 2Completed
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Clinical Evaluation of Lapatinib Administered With Capecitabine in Japanese Patients With ErbB2 Overexpressing Advanced or Metastatic Breast Cancer

GlaxoSmithKline·interventional·Posted May 23, 2007·Updated Sep 17, 2018

In Brief

A Phase 2 clinical trial evaluating Lapatinib and capecitabine for Metastatic Breast Cancer and Neoplasms, Breast. Completed, enrolled 51 participants across 15 sites.

Detailed Summary

This study is to evaluate the safety and efficacy of lapatinib taken together with capecitabine in Japanese patients. The study will proceed in two phases; the first phase(Part1) will lead to an evaluation of the mainly tolerability as well as PK parameters. If there are no major safety concerns in Part 1, the study will move into the second phase (Part 2) to further evaluate the safety and clinical activity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer, Neoplasms, Breast
CountriesJapan
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.1 years ago

Interventions

Lapatinibdrug

1250mg once daily

capecitabinedrug

2000mg/m\^2 twice daily (14 days out of 21 days)