Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT00259987
Phase
PHASE2
Status
Completed

Conditions

  • Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib (GW572016) oral tablets — DRUG

Study Details

This Phase II study will assess the efficacy, safety, and pharmacodynamics and pharmacokinetics of 1000 mg and 1500 mg lapatinib administered once daily in patients with relapsed adenocarcinoma of the esophagus, including tumors of the GE junction and gastric cardia.

Key Dates

Start date
Nov 30, 2005
Status verified
May 2009
Completion
May 31, 2007

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day) [ Time Frame: daily throughout the study ]

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90095-
GSK Investigational SiteAnn ArborMichigan48109-
GSK Investigational SiteBuffaloNew York14263-

Find similar trials in Los Angeles, CA

By research site
GSK Investigational Site· Los Angeles, CAGSK Investigational Site· Ann Arbor, MIGSK Investigational Site· Buffalo, NY

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