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An Exploratory, Phase II Trial to Determine the Association of Lapatinib Induced Fluoropyrimidine Gene Changes With Efficacy Parameters of Lapatinib and Capecitabine in First Line Gastric Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neoplasms, Gastrointestinal Tract

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Trial Information

An Exploratory, Phase II Trial to Determine the Association of Lapatinib Induced Fluoropyrimidine Gene Changes With Efficacy Parameters of Lapatinib and Capecitabine in First Line Gastric Cancer


Inclusion Criteria:



- Has signed inform consent

- Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer,
including the gastro-esophageal junction

- Tumor accessible to and patient consent for endoscopic biopsy at study start and
after 7 days of single agent Lapatinib

- Measurable disease according to RECIST criteria

- Male or female > or = 18 years of age

- Cardiac ejection fraction within the institutional range of normal as measured by
echocardiogram

- must have adequate organ function as defined by baseline laboratory values

Exclusion Criteria:

- Gastric carcinoid, sarcomas, or squamous cell cancer

- Pregnant or lactating females

- Intractable nausea, vomiting, or gastro intestinal obstruction requiring
decompression and drainage with a gastric tube or nasogastric suction.

- patients who require continuous enteral feeding

- Malabsorption syndrome or uncontrolled inflammatory GI disease (Crohn's or ulcerative
colitis

- Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart
failure

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change From Start of Run-in Period in Biomarker Expression Levels at Day 0

Outcome Description:

Participants were analyzed for intratumoral expression levels of genes involved in the 5-fluorouracil (FU) pathway and lapatinib-targeted genes. Change in biomarker expression levels was calculated as the levels measured after the lapatinib Run-in Period (Baseline) of the study minus the levels measured at the start of monotherapy (Day -7). EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor. Data are presented as ratios of the normalized gene expression of the target gene to that of beta actin.

Outcome Time Frame:

evaluated at baseline and after 7 days of study treatment

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

LPT109747

NCT ID:

NCT00526669

Start Date:

March 2008

Completion Date:

July 2013

Related Keywords:

  • Neoplasms, Gastrointestinal Tract
  • tumor biopsy
  • capecitabine
  • first line
  • Gastro Esophageal (GE) Junction Cancer
  • Gastric cancer
  • newly diagnosed
  • GE junction
  • lapatinib
  • metastatic or unresectable
  • Neoplasms
  • Digestive System Neoplasms
  • Gastrointestinal Neoplasms
  • Stomach Neoplasms

Name

Location

GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRoyal Oak, Michigan  48073