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
Results First Received: February 16, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Neoplasms, Gastrointestinal Tract
Intervention: Drug: Lapatinib and Capecitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
68 participants were enrolled in the study, as reflected by the enrollment number in the protocol record; however, one participant elected to not receive study treatment and was thus not included in the Intent-to-Treat Population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After an initial tumor biopsy (biop.), participants (par.) received lapatinib monotherapy in a 7-day Run-in Period, followed by a second biop. After the second biop., par. received a 14-day course of capecitabine in combination with lapatinib, which continued in the absence of treatment-related toxicity, until disease progression or withdrawal.

Reporting Groups
  Description
Lapatinib Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
Lapatinib + Capecitabine Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.

Participant Flow for 2 periods

Period 1:   7-Day Run-in Monotherapy Treatment Phase
    Lapatinib     Lapatinib + Capecitabine  
STARTED     67     0  
COMPLETED     67     0  
NOT COMPLETED     0     0  

Period 2:   Combined Treatment Phase
    Lapatinib     Lapatinib + Capecitabine  
STARTED     0     67  
Ongoing: In Follow-up     0     11  
COMPLETED     0     52  
NOT COMPLETED     0     15  
Lost to Follow-up                 0                 2  
Withdrawal by Subject                 0                 2  
Ongoing: In follow-up                 0                 11  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lapatinib + Capecitabine Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.

Baseline Measures
    Lapatinib + Capecitabine  
Number of Participants  
[units: participants]
  67  
Age [1]
[units: Years]
Mean ± Standard Deviation
  61.4  ± 12.57  
Gender [1]
[units: Participants]
 
Female     17  
Male     50  
Race/Ethnicity, Customized [1]
[units: participants]
 
White - White/Caucasian/European Heritage     34  
Asian - East Asian Heritage     30  
American Indian or Alaskan Native     2  
Asian - South East Asian Heritage     1  
[1] Baseline data were collected in members of the Intent-to-Treat Population, comprised of all participants who entered the study and received at least one dose of lapatinib.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   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) ]

3.  Primary:   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) ]

4.  Secondary:   PFS   [ Time Frame: From Baseline (Day 0) until disease progression or death due to any cause (up to approximately 85 weeks) ]

5.  Secondary:   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) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   Time to Response   [ Time Frame: Baseline (Day 0) until first documented evidence of response (up to approximately 60 weeks) ]

9.  Secondary:   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) ]

10.  Secondary:   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) ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   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 ]

15.  Secondary:   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 ]

16.  Secondary:   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 ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

21.  Secondary:   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 ]

22.  Secondary:   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 ]

23.  Secondary:   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 ]

24.  Secondary:   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 ]

25.  Secondary:   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 ]

26.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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