Lapatinib in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

Sponsor
GlaxoSmithKline
Study ID
NCT00477464
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    1250mg once daily
  • capecitabine — DRUG
    2000mg/m\^2 twice daily (14 days out of 21 days)

Study Details

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.

Key Dates

Start date
Jun 30, 2007
Status verified
Sep 2011
Primary completion
Dec 31, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lapatinib+capecitabine
    Lapatinib 1250mg once daily +capecitabine 2000mg/m\^2 twice daily (14 days out of 21 days)

Primary Outcome Measure

Clinical Benefit Response (Independent Reviewer-assessed) [ Time Frame: Baseline, every 6 weeks until Week 24 and then every 12 weeks until disease progression (up to Week 119) ]

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