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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

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

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

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

NCT ID

NCT00680901

First Posted

May 15, 2008

Last Updated

September 12, 2023

Sponsor

Novartis Pharmaceuticals

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

Data Monitoring Committee

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

Time Frame

From randomization until death due to any cause (average of 51 weeks)

Title

Overall Survival in All Randomized Participants

Description

Time Frame

From randomization until death due to any cause (average of 51 weeks)

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

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

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

Time Frame

From randomization until disease progression (PD) or death due to any cause (average of 30 weeks)

Title

Time to Response (TTR)

Description

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

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

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

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

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

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

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

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

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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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

Neoplasms, Gastrointestinal Tract

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial