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LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

Primary Purpose

Neoplasms, Gastrointestinal Tract

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lapatinib
Placebo
Capecitabine
Oxaliplatin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Gastrointestinal Tract focused on measuring unresectable, HER2, TYVERB, ErbB2, TYKERB, capecitabine, CapeOx, gastric/esophageal cancer, GE junction, metastatic, lapatinib, oxaliplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal junction adenocarcinoma; disease that is locally advanced (unresectable), metastatic, or locally recurrent disease; Measurable or non-measurable, but radiologically evaluable disease, according to RECIST; ErbB2 (HER2)positive; Age =18 years; ECOG Performance status = 2; Adequate organ function, including adequate hematologic, renal and liver function; Cardiac ejection fraction within institutional range of normal as measured by echocardiogram; Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube; Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study; Prior gastric surgery is permitted if > 3 weeks prior and recovered; Prior chemotherapy for non-gastric malignancy if > than 5 years; Prior neoadjuvant and/or adjuvant chemotherapy for early stage gastric cancer if > 6 months since completion; At least 4 weeks since prior radiotherapy; Prior biologic, hormonal, or immunologic cancer treatment if > 5 years since treatment.

Exclusion Criteria:

Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites; Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease; Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; Pre-existing grade = 2 motor or sensory neuropathy; Uncontrolled infection; Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject''s safety; Active hepatic or biliary disease; History of other malignancy except if disease-free for 5 years, a history of completely resected non-melanoma skin cancer, or a successfully treated in situ carcinoma; Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment; Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; Known history of DPD deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients; Use of any investigational drug within 30 days prior randomization; Use of concurrent prohibited medications that would interact with study medications

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CapeOx plus Lapatinib

CapeOx plus Placebo

Arm Description

CapeOx plus Lapatinib

CapeOx plus Placebo

Outcomes

Primary Outcome Measures

Overall Survival
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.
Overall Survival in All Randomized Participants
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)
A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).
Number of Participants With Clinical Benefit (CB)
CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.
Time to Response (TTR)
TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.
Duration of Response (DOR)
DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.
Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36
The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from "poor" to "excellent." All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.
Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36
The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.
Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36
The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant's current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.
Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).
Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.

Full Information

First Posted
May 15, 2008
Last Updated
September 12, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00680901
Brief Title
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
Official Title
A Phase III Study for ErbB2 Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Junction Adenocarcinoma Treated With Capecitabine Plus Oxaliplatin With or Without Lapatinib
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 4, 2008 (Actual)
Primary Completion Date
September 24, 2012 (Actual)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an international multi-center trial that will enroll patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors have amplification of the ErbB2 (HER2) gene. The trial will investigate whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extends the time to progression and overall survival. Tumor ErbB2 (HER2) status must be known before trial entry. CapeOx is administered to all patients, and patients will be randomly assigned to receive either lapatinib or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Gastrointestinal Tract
Keywords
unresectable, HER2, TYVERB, ErbB2, TYKERB, capecitabine, CapeOx, gastric/esophageal cancer, GE junction, metastatic, lapatinib, oxaliplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CapeOx plus Lapatinib
Arm Type
Experimental
Arm Description
CapeOx plus Lapatinib
Arm Title
CapeOx plus Placebo
Arm Type
Placebo Comparator
Arm Description
CapeOx plus Placebo
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Other Intervention Name(s)
Tykerb, Tyverb
Intervention Description
5 pills at 250mg each once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 pills once daily
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1700mg/m2/day in two daily doses
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
130mg/m2 on day 1
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.
Time Frame
From randomization until death due to any cause (average of 51 weeks)
Title
Overall Survival in All Randomized Participants
Description
Overall Survival is defined as the time from randomization until death due to any cause. Participants who had not died were censored at the follow-up visit as either follow-up ended or follow-up ongoing.
Time Frame
From randomization until death due to any cause (average of 51 weeks)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the interval between the date of randomization and the earliest date of disease progression (PD) or death due to any cause. Per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >= 1 new lesion. Participants who did not have a radiological assessed PD but had symptomatic PD were also counted. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
Time Frame
From randomization until the earliest date of disease progression or death due to any cause (average of 30 weeks)
Title
Number of Participants With a Response of Confirmed Complete Response (CR) or Confirmed Partial Response (PR)
Description
A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target and non-target lesions) or a PR (at least a 30% decrease in the sum of the longest diameters [LD] of target lesions, taking as a reference the Baseline sum LD) as assessed by the investigator (confirmed by radiographic imaging within 4 weeks from initial observations).
Time Frame
From randomization until the date of the first documented response of CR or PR (average of 9 weeks)
Title
Number of Participants With Clinical Benefit (CB)
Description
CB is defined as evidence of a CR (disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) at any time or stable disease (SD, neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started) as assessed by the investigator.
Time Frame
From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)
Title
Time to Response (TTR)
Description
TTR is defined as the time from randomization until the date of the first documented evidence of CR (the disappearance if all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking a reference the Baseline sum LD) as assessed by the investigator.
Time Frame
From Baseline (Day 1) until the first documented evidence of confirmed CR or PR (average of 9 weeks)
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first documented evidence of a CR (the disappearance of all target and non-target lesions) or PR (at least a 30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD) until the first documented sign of PD or death due to any cause. Per RECIST, PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started or the appearance of >=1 new lesion. Participants who had neither progressed nor died were censored at the follow-up visit as either follow-up ended or follow-up ongoing. Participants who received non-study anti-cancer therapies before disease progression were treated as censored.
Time Frame
From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause (average of 36 weeks)
Title
Number of Participants With Any Non-serious Adverse Event (AE: Occurring in >=5% Participants in Any Treatment Arm) or Any Serious Adverse Event (SAE)
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. Refer to the general Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame
From the first dose of study medication until 30 days after the last dose (average of 229 days)
Title
Number of Participants With Adverse Events of the Indicated Severity, Per the National Cancer Institute (NCI) Common Terminology Criteria in Adverse Events (CTCAE)
Description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury. AE/SAE severity was graded according to NCI CTCAE, version 3.0: Grade (G) 1, mild; G2, moderate; G3, severe; G4, life threatening; G5, death related to toxicity.
Time Frame
From the first dose of study medication until 30 days after the last dose (average of 229 days)
Title
Mean Change in Scores on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) From Baseline to Week 36
Description
The QLQ-C30, a self administered tool used to assess HROL, consists of 30 items that assesses 15 domains consisting of 5 functional scales (s.) (physical, role, emotional, cognitive, social) and nine symptom s. or single items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status or QOL s.. For the functional s. and symptom s. or single items, participants assessed using a 4-point s. (1=not at all; 2=a little; 3=quite a bit; 4=very much), whereas global health status or QOL was assessed using a 7-item Likert s., ranging from "poor" to "excellent." All s. and single-item scores ranged from 0 to 100. For the functional scores, a higher score indicated a better HRQOL, i.e. 0=worst HRQOL, 100=best HRQOL; for the symptom s. or single items , a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.
Time Frame
From Baseline (Day1) to Week 36
Title
Mean Change in Scores on the EORTC Quality of Life (QOL) Questionnaire of Stomach 22 (QLQ-STO22) From Baseline to Week 36
Description
The EORTC QLQ-STO22, the Gastric module of QLQ-C30, is a self administered tool use to assess HROOL of patients with gastric cancer. It consists of 22 items consisting of nine symptom scales or single items (dysphagia, pain, reflux, eating restrictions, anxiety, dry mouth, taste, body image, hair loss) that were developed for participants with gastric cancer. For the symptom scales or single items, participants assessed using a 4-point scale (1=not at all; 2=a little; 3=quite a bit; 4=very much). All scales and single-item scores ranged from 0 to 100. For the symptom scales or single items, a higher score indicated a high level of symptoms and problems, i.e. 0=no symptoms, 100=most severe symptoms.
Time Frame
From Baseline (Day1) to Week 36
Title
Mean Change in Scores on the Questionnaire EuroQoL-5 Dimensions (EQ-5D) From Baseline to Week 36
Description
The EQ-5D is a generic preference-based HROOL self administered tool comprising of a 5-dimensional health status measure (5D utility measure) and a visual analog rating scale feeling thermometer (T.). 5D utility measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. T. assesses participant's current health state. Each 5D utility question was responded to on a 3-point scale, indicating the level of impairment (1=no problem; 2=some or moderate problem(s); 3=unable, or extreme problems). The index utility values corresponding to the 243 health states were defined by the EuroQol classification and calculated based on country-specific regression coefficients. In the UK-based value set, the possible EQ-5D index utility values range from -0.594 to 1. The T. value ranges from 0 to 100. EQ-5D utility index score 0=death, 1=perfect health, -0.594 = worse than death. The T. score: 100=best imaginable health state, 0=worse imaginable health state.
Time Frame
From Baseline (Day1) to Week 36
Title
Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Clinical Chemistry Parameters
Description
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for the indicated clinical chemistry parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transeferase (AST), Total Bilirubin (TB), Calcium (Hypercalcemia and Hypocalcemia), Creatine Kinase (CK), Creatinine, Glucose (Hyperglycemia [high] and Hypoglycemia [low]), Potassium (Hyperkalemia [high] and Hypokalemia [low]), Magnesium (Hypermagnesemia [high] and Hypomagnesemia [low]), and Sodium (Hypernatremia [high] and Hyponatremia [low]).
Time Frame
From Baseline (Day 1) until 28 days after the last dose (average of 239 days)
Title
Number of Participants With a Worst-case on Therapy Grade 3 or Grade 4 for the Indicated Hematology Parameters
Description
Data are summarized by NCI CTCAE, version 3.0 toxicity grades. Data are reported as the number of participants who had a Grade 3 (G3) or Grade 4 (G4) toxicity for indicated hematology parameters: G3 indicates a severe toxicity, and G4 indicates a life-threatening toxicity. Hematology parameter included: Hemoglobin (Hemo), Total Neutrophils (TN) Absolute, Platelet Count (PC), and White Blood Cell (WBC) Count.
Time Frame
From Baseline (Day 1) until 28 days after the last dose (average of 239 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent; Histologically confirmed gastric, esophageal, or gastro-esophageal junction adenocarcinoma; disease that is locally advanced (unresectable), metastatic, or locally recurrent disease; Measurable or non-measurable, but radiologically evaluable disease, according to RECIST; ErbB2 (HER2)positive; Age =18 years; ECOG Performance status = 2; Adequate organ function, including adequate hematologic, renal and liver function; Cardiac ejection fraction within institutional range of normal as measured by echocardiogram; Able to swallow and retain oral medications, and/or receive enteral medications via gastrectomy feeding tube; Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study; Prior gastric surgery is permitted if > 3 weeks prior and recovered; Prior chemotherapy for non-gastric malignancy if > than 5 years; Prior neoadjuvant and/or adjuvant chemotherapy for early stage gastric cancer if > 6 months since completion; At least 4 weeks since prior radiotherapy; Prior biologic, hormonal, or immunologic cancer treatment if > 5 years since treatment. Exclusion Criteria: Pregnant or lactating females; Known history of active CNS disease; Uncontrolled ascites; Concurrent anti-cancer therapy; Gastric carcinoid, epidermoid, sarcomas, or squamous cell carcinoma; Prior palliative chemotherapy for the treatment of gastric cancer; Prior treatment with oxaliplatin < 12 months; Malabsorption syndrome or uncontrolled inflammatory gastrointestinal disease; Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; Pre-existing grade = 2 motor or sensory neuropathy; Uncontrolled infection; Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical condition that would interfere with the subject''s safety; Active hepatic or biliary disease; History of other malignancy except if disease-free for 5 years, a history of completely resected non-melanoma skin cancer, or a successfully treated in situ carcinoma; Unresolved or unstable serious toxicity from prior administration of another investigational drug and/or prior cancer treatment; Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; Known history of DPD deficiency; Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to lapatinib, capecitabine, fluorouracil, platins or their excipients; Use of any investigational drug within 30 days prior randomization; Use of concurrent prohibited medications that would interact with study medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Novartis Investigative Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Novartis Investigative Site
City
La Verne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
Novartis Investigative Site
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Novartis Investigative Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Novartis Investigative Site
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Novartis Investigative Site
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Novartis Investigative Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Novartis Investigative Site
City
Ciudad Aut6noma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1050AAK
Country
Argentina
Facility Name
Novartis Investigative Site
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Facility Name
Novartis Investigative Site
City
Neuquen
State/Province
Neuquén
ZIP/Postal Code
Q8300HDH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cipolletti
State/Province
Río Negro
ZIP/Postal Code
R8324EMB
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
1264
Country
Argentina
Facility Name
Novartis Investigative Site
City
La Rioja
ZIP/Postal Code
F5300COE
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-090
Country
Brazil
Facility Name
Novartis Investigative Site
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-281
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
Novartis Investigative Site
City
Florianopolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Novartis Investigative Site
City
Jau
State/Province
São Paulo
ZIP/Postal Code
17210-120
Country
Brazil
Facility Name
Novartis Investigative Site
City
Santo Andre
State/Province
São Paulo
ZIP/Postal Code
09060-650
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01308-500
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Novartis Investigative Site
City
Temuco
State/Province
Región De La Araucania
ZIP/Postal Code
481-0469
Country
Chile
Facility Name
Novartis Investigative Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
Novartis Investigative Site
City
Vina del Mar
State/Province
Valparaíso
ZIP/Postal Code
254-0364
Country
Chile
Facility Name
Novartis Investigative Site
City
Santiago
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Novartis Investigative Site
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Novartis Investigative Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Novartis Investigative Site
City
Ha Er Bin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Facility Name
Novartis Investigative Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Novartis Investigative Site
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130012
Country
China
Facility Name
Novartis Investigative Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Novartis Investigative Site
City
Fuzhou
ZIP/Postal Code
350025
Country
China
Facility Name
Novartis Investigative Site
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Facility Name
Novartis Investigative Site
City
Qingdao
ZIP/Postal Code
266061
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Novartis Investigative Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Novartis Investigative Site
City
Pokfulam
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Tuen Mun
Country
Hong Kong
Facility Name
Novartis Investigative Site
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Novartis Investigative Site
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Novartis Investigative Site
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
Novartis Investigative Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Novartis Investigative Site
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
Novartis Investigative Site
City
Calcutta
ZIP/Postal Code
700026
Country
India
Facility Name
Novartis Investigative Site
City
Coimbatore
ZIP/Postal Code
641037
Country
India
Facility Name
Novartis Investigative Site
City
Kochi
ZIP/Postal Code
682041
Country
India
Facility Name
Novartis Investigative Site
City
Kochi
Country
India
Facility Name
Novartis Investigative Site
City
Kolkata
ZIP/Postal Code
700 053
Country
India
Facility Name
Novartis Investigative Site
City
Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
Novartis Investigative Site
City
New Delhi
Country
India
Facility Name
Novartis Investigative Site
City
Parel
ZIP/Postal Code
400012
Country
India
Facility Name
Novartis Investigative Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Novartis Investigative Site
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Novartis Investigative Site
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Novartis Investigative Site
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Novartis Investigative Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Novartis Investigative Site
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Novartis Investigative Site
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
Country
Italy
Facility Name
Novartis Investigative Site
City
Rionero In Vulture (PZ)
State/Province
Basilicata
ZIP/Postal Code
85028
Country
Italy
Facility Name
Novartis Investigative Site
City
Cesena
State/Province
Emilia-Romagna
ZIP/Postal Code
47023
Country
Italy
Facility Name
Novartis Investigative Site
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Novartis Investigative Site
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
Novartis Investigative Site
City
Piacenza
State/Province
Emilia-Romagna
ZIP/Postal Code
29100
Country
Italy
Facility Name
Novartis Investigative Site
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Facility Name
Novartis Investigative Site
City
Udine
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
Novartis Investigative Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Novartis Investigative Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Novartis Investigative Site
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24128
Country
Italy
Facility Name
Novartis Investigative Site
City
Treviglio (BG)
State/Province
Lombardia
ZIP/Postal Code
24047
Country
Italy
Facility Name
Novartis Investigative Site
City
Pesasro
State/Province
Marche
ZIP/Postal Code
61122
Country
Italy
Facility Name
Novartis Investigative Site
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Novartis Investigative Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novartis Investigative Site
City
Macerata
Country
Italy
Facility Name
Novartis Investigative Site
City
Busan
ZIP/Postal Code
602-030
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Hwasun
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seodaemun-gu, Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon, Kyonggi-do
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Acapulco
State/Province
Guerrero
ZIP/Postal Code
39670
Country
Mexico
Facility Name
Novartis Investigative Site
City
Mexico City
ZIP/Postal Code
CP 14080
Country
Mexico
Facility Name
Novartis Investigative Site
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Callao
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Novartis Investigative Site
City
Lima
ZIP/Postal Code
Lima 11
Country
Peru
Facility Name
Novartis Investigative Site
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Facility Name
Novartis Investigative Site
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-226
Country
Poland
Facility Name
Novartis Investigative Site
City
Olsztyn
ZIP/Postal Code
10-513
Country
Poland
Facility Name
Novartis Investigative Site
City
Plock
ZIP/Postal Code
09-400
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Novartis Investigative Site
City
Rybnik
ZIP/Postal Code
44-200
Country
Poland
Facility Name
Novartis Investigative Site
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Novartis Investigative Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Novartis Investigative Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Novartis Investigative Site
City
San Juan
ZIP/Postal Code
00910
Country
Puerto Rico
Facility Name
Novartis Investigative Site
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kursk
ZIP/Postal Code
305035
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
ZIP/Postal Code
390011
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Saratov
ZIP/Postal Code
410004
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Sochi
ZIP/Postal Code
354057
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ufa,
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taoyuan County
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Novartis Investigative Site
City
Hatyai, Songkhla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Novartis Investigative Site
City
Gaziantep
ZIP/Postal Code
27310
Country
Turkey
Facility Name
Novartis Investigative Site
City
Trabzon
ZIP/Postal Code
61187
Country
Turkey
Facility Name
Novartis Investigative Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Dnepropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Dnipropetrovsk
ZIP/Postal Code
49100
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Donetsk
ZIP/Postal Code
83092
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kharkiv
ZIP/Postal Code
61070
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kryvyi Rih
ZIP/Postal Code
50048
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Lutsk,
ZIP/Postal Code
43018
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Lviv
ZIP/Postal Code
79031
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Odessa
ZIP/Postal Code
65055
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Plyuty
ZIP/Postal Code
08720
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Simferopil
ZIP/Postal Code
95023
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Simferopol
ZIP/Postal Code
95023
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Sumy
ZIP/Postal Code
40005
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Ternopil
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Vinnitsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Novartis Investigative Site
City
Zaporizhzhia
ZIP/Postal Code
69040
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Citations:
PubMed Identifier
27737436
Citation
Chu MP, Hecht JR, Slamon D, Wainberg ZA, Bang YJ, Hoff PM, Sobrero A, Qin S, Afenjar K, Houe V, King K, Koski S, Mulder K, Hiller JP, Scarfe A, Spratlin J, Huang YJ, Khan-Wasti S, Chua N, Sawyer MB. Association of Proton Pump Inhibitors and Capecitabine Efficacy in Advanced Gastroesophageal Cancer: Secondary Analysis of the TRIO-013/LOGiC Randomized Clinical Trial. JAMA Oncol. 2017 Jun 1;3(6):767-773. doi: 10.1001/jamaoncol.2016.3358. Erratum In: JAMA Oncol. 2017 Dec 1;3(12):1742.
Results Reference
derived
PubMed Identifier
26628478
Citation
Hecht JR, Bang YJ, Qin SK, Chung HC, Xu JM, Park JO, Jeziorski K, Shparyk Y, Hoff PM, Sobrero A, Salman P, Li J, Protsenko SA, Wainberg ZA, Buyse M, Afenjar K, Houe V, Garcia A, Kaneko T, Huang Y, Khan-Wasti S, Santillana S, Press MF, Slamon D. Lapatinib in Combination With Capecitabine Plus Oxaliplatin in Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Gastric, Esophageal, or Gastroesophageal Adenocarcinoma: TRIO-013/LOGiC--A Randomized Phase III Trial. J Clin Oncol. 2016 Feb 10;34(5):443-51. doi: 10.1200/JCO.2015.62.6598. Epub 2015 Nov 30.
Results Reference
derived

Learn more about this trial

LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib

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