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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00526669
First received: September 6, 2007
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Neoplasms, Gastrointestinal Tract
Drug: Lapatinib and Capecitabine
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Start of Run-in Period in Biomarker Expression Levels at Day 0 [ Time Frame: evaluated at baseline and after 7 days of study treatment ] [ Designated as safety issue: No ]
    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.

  • Response Rate (Measured as the Percentage of Participants With Response [Complete Response or Partial Response]) [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks) ] [ Designated as safety issue: No ]
    Response is defined as documented evidence of complete response (CR) or partial response (PR). The investigator evaluated response based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Complete response is defined as the disappearance of all target lesions (TLs) and non-TLs and the appearance of no new lesions (NLs). Partial response for TLs is defined as >= a 30% decrease in the sum of the longest diameter (LD) of TLs, taking as a reference the Baseline sum LD. For non-TLs it is defined as the persistence of 1 or more non-TL and no new TLs or non-TLs.

  • Percentage of Participants (Par.) With 5-month Progression-free Survival (PFS) [ Time Frame: From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease) ] [ Designated as safety issue: No ]
    5-month (mo.) PFS was defined as the percentage of par. who were alive/progression free for 5 months from the time of initial treatment. PFS is defined as the time from the initial treatment until the first observation of disease progression (DP)/death due to any cause; the percentage of par. whose follow-up ended or was ongoing was reported. DP is defined as symptomatic progression or the appearance of >=1 NL and/or unequivocal progression of existing non-TLs, and a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started.


Secondary Outcome Measures:
  • PFS [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) ] [ Designated as safety issue: No ]
    PFS is defined as the time from the initial treatment until the first observation of disease progression or death due to any cause. The date of documented disease progression was defined as the earliest date of radiographic disease assessment progression or symptomatic progression, whichever came first. For participants who did not die/progress, survival was censored at the time of the last assessment (or contact).

  • Overall Survival (OS) [ Time Frame: From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks) ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from the initial treatment until death due to any cause. A death occurring during the study is defined as a death occurring during treatment or within 30 days of the last administration of study medication.

  • Time to Progression (All Deaths Are Treated as Competing Risk) [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) ] [ Designated as safety issue: No ]
    Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.

  • Time to Progression (All Deaths Due to Non-PD Are Treated as Competing Risk) [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) ] [ Designated as safety issue: No ]
    Time to progression is defined as the time from the initial treatment (first dose) until the first documented radiological symptomatic sign of disease progression. Time to progression data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of occurrence of a particular event is reached to a particular point. All factors that hinder the observation of the event are defined as competing risks.

  • Time to Response [ Time Frame: Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks) ] [ Designated as safety issue: No ]
    Time to response is defined as the time from the initial treatment until the first documented evidence of CR (disappearance of all TLs and non-TLs and the appearance of no new lesions) or PR (>= a 30% decrease in the sum of the longest diameter of TLs, taking as reference the Baseline sum longest diameter) (whichever status was recorded first). Time to response data are presented as cumulative incidence estimate, which is defined as the time from the initial treatment until crude hazard probability of the occurrence of a particular event is reached to a particular point.

  • Duration of Response [ Time Frame: From date of first documented evidence of response until the date of first documented sign of disease progression or death due to any cause (up to approximately 78 weeks) ] [ Designated as safety issue: No ]
    Duration of response is defined as the time from the first documented evidence of tumor response (CR or PR) until the first documented sign of disease progression or death due to any cause, whichever came first.

  • Number of Participants in the Indicated Categories for Best Overall Response (BOR) [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) ] [ Designated as safety issue: No ]
    Best overall response was evaluated by the investigator based on RECIST criteria: CR; PR; Stable Disease (SD), defined as no sufficient shrinkage to qualify for PR, no sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; PD, defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >= 1 new lesions; Unknown, defined as participants who do not have CR, PR, SD, or PD.

  • 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 [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Toxicity was measured in grades (AE severity) per National Cancer Institute Common Toxicity Criteria for Adverse Event (NCI CTCAE) version (v) 3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For albumin (per blood samples): G 1 (<lower limit of normal [LLN] to 3 grams per deciliter [g/dL]), mild; G 2 (<3 to 2 g/dL), moderate; G 3 (<2 g/dL), severe; G 4 (value not available), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • 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 [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALP: G 1 (upper limit of normal [ULN] to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • 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 [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of AST. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For AST: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • 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 [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of ALT. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For ALT: G 1 (>ULN to 2.5x ULN), mild; G 2 (>2.5 to 5.0x ULN), moderate; G 3 (>5.0 to 20.0x ULN), severe; G 4 (>20.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Bilirubin at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of total bilirubin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For total bilirubin: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 10.0x ULN), severe; G 4 (>10.0x ULN), life threatening/disabling; G 5 (value not available), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Calcium at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for calcium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For calcium (low and high, respectively): G 1 (<LLN to 8.0 mg/dL; >ULN to 11.5x ULN), mild; G 2 (<8.0 to 7.0 mg/dL; >11.5 to 12.5 ULN), moderate; G 3 (<7.0 to 6.0 mg/dL; >12.5 to 13.5 mg/dL), severe; G 4 (<6 mg/dL; >13.5 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Creatinine at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of creatinine. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For creatinine: G 1 (>ULN to 1.5x ULN), mild; G 2 (>1.5 to 3.0x ULN), moderate; G 3 (>3.0 to 6.0x ULN), severe; G 4 (>6.0x ULN), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Glucose at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of glucose. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For glucose (high and low, respectively): G 1 (>ULN to 160 mg/dL; <LLN to 55 mg/dL), mild; G 2 (>160 to 250 mg/dL; <55 to 40 mg/dL), moderate; G 3 (>250 to 500 mg/dL; <40 to 30 mg/dL), severe; G 4 (>500 mg/dL; <30 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Potassium at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For potassium (high and low [per blood samples], respectively): G 1 (>ULN to 5.5 millimoles per liter [mmol/L]; <LLN to 3.0 mmol/L), mild; G 2 (>5.5 to 6.0 mmol/L; value not available), moderate; G 3 (>6.0 to 7.0 mmol/L; <3.0 to 2.5 mmol/L), severe; G 4 (>7.0 mmol/L; <2.5 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Magnesium at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for magnesium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For magnesium (high and low, respectively): G 1 (>ULN to 3.0 mg/dL; <LLN to 1.2 mg/dL), mild; G 2 (value not available; <1.2 to 0.9 mg/dL), moderate; G 3 (>3.0 to 8.0 mg/dL; <0.9 to 0.7 mg/dL), severe; G 4 (>8.0 mg/dL; <0.7 mg/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Sodium at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for sodium evaluation. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of each AE severity. For sodium (high and low, respectively): G 1 (>ULN to 150 mmol/L; <LLN to 130 mmol/L), mild; G 2 (>150 to 155 mmol/L; value not available), moderate; G 3 (>155 to 160 mmol/L; <130 to 120 mmol/L), severe; G 4 (>160 mmol/L; <120 mmol/L), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Hemoglobin at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of hemoglobin. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For hemoglobin: G 1 (<LLN to 10 g/dL), mild; G 2 (<10.0 to 8.0 g/dL), moderate; G 3 (<8.0 to 6.5 g/dL), severe; G 4 (<6.5 g/dL), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Lymphocytes at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of lymphocytes. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For lymphocytes: G 1, mild; G 2, moderate; G 3, severe; G 4, life threatening/disabling; G 5, death related to AE; ranges were provided by local laboratories. Change from Baseline was measured as any grade increase (AGI), increase to G 3 (ItoG3), and increase to G 4 (ItoG4). Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Total Neutrophils at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of total neutrophils. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For neutrophils: G 1 (<LLN to 1500/millimeters cubed [mm^3] of blood plasma [bp]), mild; G 2 (<1500 to 1000/mm^3 of bp), moderate; G 3 (<1000 to 500/mm^3 of bp), severe; G 4 (<500/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • Number of Participants With Change From Baseline (Measured as AGI, ItoG3, and ItoG4) in Toxicity Grades for Platelet Count at the Indicated Time Points [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of platelet count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For platelet count: G 1 (<LLN to 75000/mm^3 of blood plasma [bp]), mild; G 2 (<75000 to 50000/mm^3 of bp), moderate; G 3 (<50000 to 25000/mm^3 of bp), severe; G 4 (<25000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.

  • 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 [ Time Frame: Baseline (Day 0); Weeks 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, and 84; withdrawal (WD)/study conclusion (up to approximately 87 weeks); and worst-case on-therapy ] [ Designated as safety issue: No ]
    Blood samples were collected for the evaluation of WBC count. Toxicity was measured in grades (AE severity) per NCI CTCAE, v3.0, displaying Grades (G) 1-5 with unique clinical descriptions of the severity of each AE. For WBCs: G 1 (<LLN to 3000/mm^3 of blood plasma [bp]), mild; G 2 (<3000 to 2000/mm^3 of bp), moderate; G 3 (<2000 to 1000/mm^3 of bp), severe; G 4 (<1000/mm^3 of bp), life threatening/disabling; G 5 (death), death related to AE. Worst-case on-therapy reflects the most severe change at any time point measured post treatment.


Enrollment: 68
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lapatinib and Capecitabine
    oral lapatinib (1250mg) administered as a monotherapy run-in followed by its combination with capecitabine
    Other Name: Lapatinib and Capecitabine
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526669

Locations
United States, California
GSK Investigational Site
Loma Linda, California, United States, 92354
GSK Investigational Site
Los Angeles, California, United States, 90033
United States, District of Columbia
GSK Investigational Site
Washington, District of Columbia, United States, 20007
United States, Louisiana
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
GSK Investigational Site
Southgate, Michigan, United States, 48195
United States, Missouri
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75137
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Korea, Republic of
GSK Investigational Site
Hwasun, Korea, Republic of, 519-809
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Mexico
GSK Investigational Site
Mexico City, Mexico, CP 14080
Russian Federation
GSK Investigational Site
Astrakhan, Russian Federation, 414044
GSK Investigational Site
Chelyabinsk, Russian Federation, 454087
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
Ufa,, Russian Federation, 450054
Taiwan
GSK Investigational Site
Changhua, Taiwan, 500
GSK Investigational Site
Taipei, Taiwan, 112
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Taipei, Taiwan, 104
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00526669     History of Changes
Other Study ID Numbers: LPT109747
Study First Received: September 6, 2007
Results First Received: February 16, 2012
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
tumor biopsy
capecitabine
first line
Gastro Esophageal (GE) Junction Cancer
Gastric cancer
newly diagnosed
GE junction
lapatinib
metastatic or unresectable

Additional relevant MeSH terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Stomach Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms
Neoplasms by Site
Stomach Diseases
Capecitabine
Fluorouracil
Lapatinib
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014