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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Adenocarcinoma

Thank you

Trial Information

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

Inclusion Criteria


Inclusion criteria:

- Has a histologically confirmed adenocarcinoma of the esophagus.

- GE (gastroesophageal) junction or gastric cardia.

- Must be of non-child-bearing potential or is of child-bearing potential.

- Have a negative serum pregnancy test and agree to an approved form of birth control.

- Have an ECOG (Eastern Cooperative Oncology Group) Performance status less than or
equal to 2.

- Have a life expectancy of at least 12 weeks.

- Have provided written informed consent.

- Investigator considers patient to be fit for study from lab test results and
interview.

Exclusion criteria:

- Pregnant or lactating female.

- Prior resection of the small bowel.

- Received major surgery.

- Received prior radiation therapy to the mediastinum or abdomen.

- Has a known immediate or delayed hypersensitivity reaction.

- Idiosyncrasy to drugs chemically related to the study drug.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)

Outcome Time Frame:

daily throughout the study

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

EGF102980

NCT ID:

NCT00259987

Start Date:

November 2005

Completion Date:

May 2007

Related Keywords:

  • Adenocarcinoma
  • relapsed adenocarcinoma
  • esophagus
  • tumors
  • GE junction
  • cancer
  • lapatinib
  • gastric cardia
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteNew York, New York  10021