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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00259987
First received: November 30, 2005
Last updated: May 15, 2009
Last verified: May 2009
History of Changes

November 30, 2005
May 15, 2009
November 2005
Not Provided
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 ]
To evaluate objective response rate (ORR) of treatment with daily lapatinib at two different doses (1000 mg and 1500 mg per day)
Complete list of historical versions of study NCT00259987 on ClinicalTrials.gov Archive Site
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 ]
To evaluate 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.
Not Provided
Not Provided
 
Effects Of Lapatinib (GW572016) In Patients With Relapsed Adenocarcinoma Of The Esophagus
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Adenocarcinoma
Drug: Lapatinib (GW572016) oral tablets
Other Name: Lapatinib (GW572016) oral tablets
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
May 2007
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Netherlands,   Peru
 
NCT00259987
EGF102980
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP