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Study For Patients With Untreated Gastric Cancer Who Will Receive Capecitabine And Lapatinib

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neoplasms, Gastrointestinal Tract

Intervention: Lapatinib and Capecitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

The study will determine if changes in expression of markers involved in the 5-FU pathways are associated with response to treatment with the combination of lapatinib and capecitabine independent of tumor erbB2 status.

Clinical Details

Official title: 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

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

Primary outcome:

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

Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response])

Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS)

Secondary outcome:

PFS

Overall Survival (OS)

Time to Progression (All Deaths Are Treated as Competing Risk)

Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk)

Time to Response

Duration of Response

Number of Participants in the Indicated Categories for Best Overall Response (BOR)

Number of Participants With Change From Baseline (Measured as Any Grade Increase [AGI], Increase to Grade 3 [ItoG3], and Increase to Grade 4 [ItoG4]) in Toxicity Grades for Albumin at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Alkaline Phosphatase (ALP) at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Aspartate Aminotransferase (AST) at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4 ) in Toxicity Grades for Alanine Aminotransferase (ALT) at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points

Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for White Blood Cell (WBC) Count at the Indicated Time Points

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

GSK Investigational Site, Hwasun 519-809, Korea, Republic of

GSK Investigational Site, Seoul 110-744, Korea, Republic of

GSK Investigational Site, Seoul 120-752, Korea, Republic of

GSK Investigational Site, Suwon, Gyeonggi-do 442-723, Korea, Republic of

GSK Investigational Site, Mexico City CP 14080, Mexico

GSK Investigational Site, Astrakhan 414044, Russian Federation

GSK Investigational Site, Chelyabinsk 454087, Russian Federation

GSK Investigational Site, St. Petersburg 197022, Russian Federation

GSK Investigational Site, Ufa, 450054, Russian Federation

GSK Investigational Site, Changhua 500, Taiwan

GSK Investigational Site, Taipei 100, Taiwan

GSK Investigational Site, Taipei 104, Taiwan

GSK Investigational Site, Taipei 112, Taiwan

GSK Investigational Site, Loma Linda, California 92354, United States

GSK Investigational Site, Los Angeles, California 90033, United States

GSK Investigational Site, Washington, District of Columbia 20007, United States

GSK Investigational Site, Shreveport, Louisiana 71103, United States

GSK Investigational Site, Ann Arbor, Michigan 48109, United States

GSK Investigational Site, Southgate, Michigan 48195, United States

GSK Investigational Site, Jefferson City, Missouri 65109, United States

GSK Investigational Site, Montreal, Quebec H3T 1E2, Canada

GSK Investigational Site, Dallas, Texas 75137, United States

Additional Information

Starting date: March 2008
Last updated: July 27, 2015

Page last updated: August 20, 2015

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