Viewing Study NCT00103324



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00103324
Status: COMPLETED
Last Update Posted: 2013-01-17
First Post: 2005-02-07

Brief Title: S0413 Lapatinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase II Study of GW572016 NSC-727989 as First Line Therapy in Patients With Advanced or Metastatic Gastric Cancer
Status: COMPLETED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This phase II trial is studying how well lapatinib works in treating patients with locally advanced or metastatic stomach cancer Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description: PRIMARY OBJECTIVES

I To assess the confirmed response complete and partial probability in patients with advancedmetastatic gastric cancer treated with GW572016

II To assess the time to treatment failure and overall survival in this group of patients

III To assess the qualitative and quantitative toxicities associated with this regimen

IV To assess in a preliminary manner the relationship of protein expression and gene expression of EGFR HER2 and markers of angiogenesis with clinical outcomes in patients treated with GW572016

OUTLINE This is a multicenter study

Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

After completion of study treatment patients are followed every 3 months for up to 2 years

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000409575 REGISTRY PDQ Physician Data Query None
S0413 None None None
U01CA32102 OTHER_GRANT None None