A Phase II, Open-Label Study Evaluating Clinical Efficacy, Safety, Pharmacokinetic and Pharmacodynamic Effects of Lapatinib (GW572016) in Patients With Relapsed Adenocarcinoma of the Esophagus, Including Tumors of the Gastroesophageal Junction and Gastric Cardia

GlaxoSmithKline1 site in 1 country24 target enrollmentNovember 2005

ConditionsAdenocarcinoma

DrugsLapatinib (GW572016) oral tablets

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Adenocarcinoma
Sponsor: GlaxoSmithKline
Enrollment: 24
Locations: 1
Primary Endpoint: Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

May 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

Safety and clinical benefit of lapatinib therapy, progression-free survival, and response duration in the two dose levels combined as well as for the two doses separately.(throughout the study)