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

Adenocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259987
• Other study ID #: EGF102980
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2005
• Last updated: May 15, 2009
• Start date: November 2005
• Est. completion date: May 2007

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationEuropean Union: European Medicines AgencyPeru: General Directorate of Pharmaceuticals, Devices, and Drugs
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00345995

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Lapatinib (GW572016) oral tablets

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Amsterdam
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	San Isidro	Lima
United States	GSK Investigational Site	Ann Arbor	Michigan
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Netherlands,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)		daily throughout the study
Secondary	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