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OpenTrials
Completed

NCT Number: NCT00259987

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

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.

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Key information

Conditions

Adenocarcinoma Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lapatinib (GW572016) oral tablets

Drug

Primary outcomes

  1. 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

  1. 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.

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Study completion
2007
First posted
Dec 1, 2005
Registry last updated
May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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