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

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

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.  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 ]