Last updated: 11/04/2018 08:59:30
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

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

GSK study ID
LPT109747
See study documents
Clinicaltrials.gov ID
NCT00526669
See results summary
EudraCT ID
2007-000531-26
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Change from start of Run-in Period in biomarker expression levels at Day 0

Timeframe: evaluated at baseline and after 7 days of study treatment

Response rate (measured as the percentage of participants with response [complete response or partial response])

Timeframe: From Baseline (Day 0) until disease progression or death due to any cause evaluated every 6 or 12 weeks (up to approximately 85 weeks)

Percentage of participants (par.) with 5-month progression-free survival (PFS)

Timeframe: From initial treatment up to 24 weeks (next available assessment after the 5-month assessment for progressive disease)

Secondary outcomes:

PFS

Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

Overall Survival (OS)

Timeframe: From Baseline (Day 0) until death due to any cause evaluated at approximately 12 months (up to approximately 100 weeks)

Time to progression (all deaths are treated as competing risk)

Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

Time to progression (all deaths due to non-PD are treated as competing risk)

Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

Time to response

Timeframe: Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks)

Duration of response

Timeframe: 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)

Number of participants in the indicated categories for best overall response (BOR)

Timeframe: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks)

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

Timeframe: 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

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

Timeframe: 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

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

Timeframe: 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

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

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for total bilirubin at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for calcium at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for creatinine at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for glucose at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for potassium at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for magnesium at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for sodium at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for hemoglobin at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for lymphocytes at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for total neutrophils at the indicated time points

Timeframe: 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

Number of participants with change from Baseline (measured as AGI, ItoG3, and ItoG4) in toxicity grades for platelet count at the indicated time points

Timeframe: 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

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

Timeframe: 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

Interventions:
Drug: Lapatinib and Capecitabine
Enrollment:
68
Observational study model:
Not applicable
Primary completion date:
2011-13-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Gastrointestinal Tract
Product
lapatinib
Collaborators
Not applicable
Study date(s)
March 2008 to January 2015
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Has signed inform consent
  • Untreated, newly diagnosed, advanced metastatic or unresectable gastric cancer, including the gastro-esophageal junction
  • Gastric carcinoid, sarcomas, or squamous cell cancer
  • Pregnant or lactating females
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Southgate, Michigan, United States, 48195
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Los Angeles, California, United States, 90033
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Seoul, South Korea, 120-752
Status
Study Complete
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Location
GSK Investigational Site
Mexico City, Mexico, CP 14080
Status
Study Complete
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Location
GSK Investigational Site
Changhua, Taiwan, 500
Status
Study Complete
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Location
GSK Investigational Site
Chelyabinsk, Russia, 454087
Status
Study Complete
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Location
GSK Investigational Site
Suwon, Gyeonggi-do, South Korea, 442-723
Status
Study Complete
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Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Study Complete
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Location
GSK Investigational Site
Dallas, Texas, United States, 75137
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Recruiting
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Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Astrakhan, Russia, 414044
Status
Study Complete
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Location
GSK Investigational Site
Taipei, Taiwan, 112
Status
Study Complete
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Location
GSK Investigational Site
Washington, District of Columbia, United States, 20007
Status
Study Complete
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Location
GSK Investigational Site
Taipei, Taiwan, 100
Status
Study Complete
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Location
GSK Investigational Site
Hwasun, South Korea, 519-809
Status
Study Complete
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Location
GSK Investigational Site
Ufa,, Russia, 450054
Status
Study Complete
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Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Study Complete
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Location
GSK Investigational Site
Montreal, Québec, Canada, H3T 1E2
Status
Study Complete
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Location
GSK Investigational Site
St. Petersburg, Russia, 197022
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
No longer a GSK study
Actual primary completion date
2011-13-04
Actual study completion date
2015-20-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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Access to clinical trial data by researchers
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